Trial Condition(s):

Carcinoma, Renal Cell

Treatment Protocol for the use of Sorafenib in Patients with Advanced Renal Cell Carcinoma

Bayer Identifier:

11868

ClinicalTrials.gov Identifier:

NCT00111020

EudraCT Number:

Not Available

EU CT Number:

Not Available

Study Completed

Trial Purpose

This treatment protocol allows doctors to treat advanced kidney cancer with an investigational drug called sorafenib, BAY43-9006, which is being studied in clinical trials for kidney cancer and other kinds of cancer. This treatment protocol is not a clinical trial in which sorafenib is compared to another equal treatment. All patients in this protocol will be treated with sorafenib. In addition, data from the patients who participate in this protocol will provide additional information about the drug.

Inclusion Criteria
- Patients with advanced (unresectable, recurrent or metastatic) RCC
 - Patients reasonably likely to benefit from treatment with sorafenib as a single agent therapy 
 - Patients with an ECOG performance status of 0-2 
 - Patients who will not require other systemic anticancer therapy (except for bisphosphonates) while taking sorafenib  
 - Patients with vascular diseases such as wet macular degeneration, vasculitis, or new peptic ulcer, may be enrolled but require close monitoring in accordance with established medical practice
Exclusion Criteria
- Patients who are currently enrolled in, are eligible for, or have access to, any other sorafenib clinical trial
 - Patients who have participated in any other sorafenib trial
 - Patients who have had prior therapy with investigational agent(s) within the last four weeks prior to study entry
 - Life expectancy of less than two months
 - Patients with cardiac arrhythmias greater than grade 1 NCI CTCAE, Version 3.0
 - Patients with active coronary artery disease or ischemia
 - Patients with Child-Pugh class C hepatic impairment
 - Patients with severe renal impairment or who require dialysis
 - Patients with active uncontrolled hypertension
 - Patients with recent or active bleeding diathesis

Trial Summary

Enrollment Goal
2567
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Glens Falls, United States, 12801

Status
Completed
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Investigative Site

Montreal, Canada, H2W 1S6

Status
Completed
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Investigative Site

Weston, United States, 33331

Status
Completed
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Investigative Site

New Haven, United States, 6520

Status
Completed
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Investigative Site

Peoria, United States, 61615

Status
Completed
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Investigative Site

Marshfield, United States, 54449

Status
Completed
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Investigative Site

Harrisburg, United States, 17111

Status
Completed
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Investigative Site

Ogden, United States, 84403

Status
Completed
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Investigative Site

Baton Rouge, United States, 70809

Status
Completed
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Investigative Site

Pensacola, United States, 32501

Status
Completed
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Investigative Site

North Charleston, United States, 29406

Status
Completed
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Investigative Site

San Antonio, United States, 78229

Status
Completed
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Investigative Site

Milwaukee, United States, 53226

Status
Completed
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Investigative Site

Philadelphia, United States, 19114

Status
Completed
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Investigative Site

Nashville, United States, 37203

Status
Completed
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Investigative Site

Loma Linda, United States, 92357

Status
Completed
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Investigative Site

Temple, United States, 76502

Status
Completed
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Investigative Site

Greenville, United States, 27834

Status
Completed
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Investigative Site

Seattle, United States, 98101

Status
Completed
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Investigative Site

Green Bay, United States, 54301

Status
Completed
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Investigative Site

Baltimore, United States, 21204

Status
Completed
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Minneapolis, United States, 55455

Status
Completed
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Investigative Site

St Louis Park, United States, 55416

Status
Completed
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Investigative Site

Hackensack, United States, 7601

Status
Completed
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Investigative Site

Aurora, United States, 80045 

Status
Completed
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Investigative Site

East Orange, United States, 7018

Status
Completed
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Investigative Site

Chapel Hill, United States, 27599

Status
Completed
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Investigative Site

Springfield, United States, 1104

Status
Completed
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Investigative Site

Vallejo, United States, 94589

Status
Completed
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Fountain Valley, United States, 92708

Status
Completed
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Olathe, United States, 66061

Status
Completed
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Investigative Site

TAMC, United States, 96859

Status
Completed
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Investigative Site

Lawton, United States, 73505

Status
Completed
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Investigative Site

Dallas, United States, 75230

Status
Completed
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New Brunswick, United States, 08902

Status
Completed
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Investigative Site

Fargo, United States, 58122

Status
Completed
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Investigative Site

Madison, United States, 53715

Status
Completed
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Investigative Site

Hermitage, United States, 16148

Status
Completed
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Investigative Site

Chicago, United States, 60637

Status
Completed
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Investigative Site

Rancho Mirage, United States, 92270

Status
Completed
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Investigative Site

St Joseph, United States, 64507

Status
Completed
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Investigative Site

Monongahela, United States, 15063

Status
Completed
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Cullman, United States, 35058

Status
Completed
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Goshen, United States, 46526

Status
Completed
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Canton, United States, 44710

Status
Completed
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Midwest City, United States, 73110

Status
Completed
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Fargo, United States, 58108

Status
Completed
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Utica, United States, 13502

Status
Completed
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Arlington, United States, 76012

Status
Completed
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Huntington, United States, 25702

Status
Completed
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Springfield, United States, 62701

Status
Completed
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Lakeland, United States, 33805

Status
Completed
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Salt Lake City, United States, 84112

Status
Completed
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Las Vegas, United States, 89109

Status
Completed
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Investigative Site

Fort Myers, United States, 33901

Status
Completed
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Investigative Site

San Antonio, United States, 78212

Status
Completed
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Investigative Site

Dayton, United States, 45429

Status
Completed
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Investigative Site

Jamaica, United States, 11432

Status
Completed
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Investigative Site

Daytona Beach, United States, 32114

Status
Completed
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Investigative Site

Richmond, United States, 23294

Status
Completed
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Investigative Site

Chevy Chase, United States, 20815

Status
Completed
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Investigative Site

Las Vegas, United States, 89106 

Status
Completed
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Investigative Site

St Louis Park, United States, 55426

Status
Completed
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Investigative Site

Beech Grove, United States, 46107

Status
Completed
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Investigative Site

Hot Springs, United States, 71913

Status
Completed
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Investigative Site

Greenwich, United States, 06830

Status
Completed
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Investigative Site

Charlotte, United States, 28204

Status
Completed
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Investigative Site

Colorado Springs, United States, 80907

Status
Completed
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Investigative Site

Missoula, United States, 59807

Status
Completed
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Investigative Site

Lancaster, United States, 17604

Status
Completed
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Investigative Site

Springdale, United States, 72764

Status
Completed
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Investigative Site

MT Clemens, United States, 48043

Status
Completed
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Investigative Site

Newark, United States, 07112

Status
Completed
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Investigative Site

Middletown, United States, 45042

Status
Completed
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Investigative Site

Bakersfield, United States, 93309

Status
Completed
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Investigative Site

Portsmouth, United States, 03801

Status
Completed
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Investigative Site

Bismarck, United States, 58501

Status
Completed
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Investigative Site

Milford, United States, 01757

Status
Completed
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Investigative Site

Philadelphia, United States, 19111

Status
Completed
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Investigative Site

Columbus, United States, 43214

Status
Completed
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Investigative Site

San Diego, United States, 92120

Status
Completed
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Investigative Site

Los Angeles, United States, 90033

Status
Completed
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Investigative Site

St Louis, United States, 63110

Status
Completed
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Investigative Site

Memphis, United States, 38120

Status
Completed
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Investigative Site

Detroit, United States, 48202

Status
Completed
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Investigative Site

East Stroudsburg, United States, 18301

Status
Completed
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Investigative Site

Denver, United States, 80210

Status
Completed
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Investigative Site

Hutchinson, United States, 67502

Status
Completed
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Investigative Site

Stony Brook, United States, 11794

Status
Completed
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Investigative Site

Albuquerque, United States, 87106

Status
Completed
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Investigative Site

Charleston, United States, 29403

Status
Completed
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Investigative Site

New York, United States, 10021

Status
Completed
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Investigative Site

Fort Worth, United States, 76104

Status
Completed
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Investigative Site

Cedar Rapids, United States, 52402

Status
Completed
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Investigative Site

Clinton Township, United States, 48038

Status
Completed
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Investigative Site

Baltimore, United States, 21237

Status
Completed
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Investigative Site

Marquette, United States, 49855

Status
Completed
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Investigative Site

Sunnyvale, United States, 94086

Status
Completed
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Investigative Site

Concord, United States, 94520

Status
Completed
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Investigative Site

Bronx, United States, 10469

Status
Completed
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Investigative Site

Lynchburg, United States, 24501

Status
Completed
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Investigative Site

Columbus, United States, 31904

Status
Completed
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Investigative Site

Lawrence, United States, 66044

Status
Completed
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Investigative Site

Charleston, United States, 25304

Status
Completed
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Investigative Site

Dallas, United States, 75237

Status
Completed
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Investigative Site

Bend, United States, 97701

Status
Completed
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Investigative Site

Clinton, United States, 20735

Status
Completed
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Investigative Site

Lincoln, United States, 68506

Status
Completed
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Investigative Site

Baltimore, United States, 21239

Status
Completed
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Investigative Site

Detroit, United States, 48201

Status
Completed
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Investigative Site

La Jolla, United States, 92093

Status
Completed
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Investigative Site

Charlottesville, United States, 22908

Status
Completed
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Investigative Site

Clarksville, United States, 37043

Status
Completed
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Investigative Site

Poughkeepsie, United States, 12601

Status
Completed
Locations

Investigative Site

Columbus, United States, 43235

Status
Completed
Locations

Investigative Site

Columbus, United States, 43213

Status
Completed
Locations

Investigative Site

New York, United States, 10032

Status
Completed
Locations

Investigative Site

Pottsville, United States, 17901

Status
Completed
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Investigative Site

Houma, United States, 70360

Status
Completed
Locations

Investigative Site

Setauket, United States, 11733

Status
Completed
Locations

Investigative Site

Lafayette, United States, 80026

Status
Completed
Locations

Investigative Site

Dunmore, United States, 18512

Status
Completed
Locations

Investigative Site

Memphis, United States, 38119

Status
Completed
Locations

Investigative Site

Armonk, United States, 10504

Status
Completed
Locations

Investigative Site

Rockville, United States, 20850

Status
Completed
Locations

Investigative Site

State College, United States, 16803

Status
Completed
Locations

Investigative Site

Austin, United States, 78705

Status
Completed
Locations

Investigative Site

York, United States, 17403

Status
Completed
Locations

Investigative Site

La Jolla, United States, 92037

Status
Completed
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Investigative Site

Newport Beach, United States, 92663

Status
Completed
Locations

Investigative Site

Orange, United States, 92868

Status
Completed
Locations

Investigative Site

Los Angeles, United States, 90025

Status
Completed
Locations

Investigative Site

Lincoln, United States, 68510

Status
Completed
Locations

Investigative Site

Pensacola, United States, 32514

Status
Completed
Locations

Investigative Site

Burlington, United States, 27215

Status
Completed
Locations

Investigative Site

Urbana, United States, 61801

Status
Completed
Locations

Investigative Site

Glendale, United States, 53212

Status
Completed
Locations

Investigative Site

Salinas, United States, 93901

Status
Completed
Locations

Investigative Site

Cooperstown, United States, 13326

Status
Completed
Locations

Investigative Site

Williamsville, United States, 14221

Status
Completed
Locations

Investigative Site

Tyler, United States, 75701

Status
Completed
Locations

Investigative Site

Mayfield Heights, United States, 44124

Status
Completed
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Investigative Site

St Petersburg, United States, 33705

Status
Completed
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Investigative Site

Indianapolis, United States, 46256

Status
Completed
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Investigative Site

Wausau, United States, 54401

Status
Completed
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Investigative Site

Tucson, United States, 85704

Status
Completed
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Investigative Site

Bayshore, United States, 11706

Status
Completed
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Investigative Site

Albuquerque, United States, 87108

Status
Completed
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Investigative Site

Rochester, United States, 14642

Status
Completed
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Investigative Site

Gainesville, United States, 32610

Status
Completed
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Investigative Site

Boca Raton, United States, 33486

Status
Completed
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Investigative Site

Bennington, United States, 5201

Status
Completed
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Investigative Site

Seattle, United States, 98104

Status
Completed
Locations

Investigative Site

Muskegon, United States, 49443

Status
Completed
Locations

Investigative Site

Bethlehem, United States, 18015

Status
Completed
Locations

Investigative Site

St Louis, United States, 63136

Status
Completed
Locations

Investigative Site

Indianapolis, United States, 46254

Status
Completed
Locations

Investigative Site

Dubuqe, United States, 52001

Status
Completed
Locations

Investigative Site

Laporte, United States, 46350

Status
Completed
Locations

Investigative Site

Duluth, United States, 55805

Status
Completed
Locations

Investigative Site

Albany, United States, 31701

Status
Completed
Locations

Investigative Site

Stuart, United States, 34994

Status
Completed
Locations

Investigative Site

Kinston, United States, 28501

Status
Completed
Locations

Investigative Site

South Bend, United States, 46601

Status
Completed
Locations

Investigative Site

Chicago, United States, 60640

Status
Completed
Locations

Investigative Site

Anchorage, United States, 99508

Status
Completed
Locations

Investigative Site

Miami, United States, 33136

Status
Completed
Locations

Investigative Site

Miami Beach, United States, 33140

Status
Completed
Locations

Investigative Site

Springfield, United States, 65804

Status
Completed
Locations

Investigative Site

Scottsdale, United States, 85258

Status
Completed
Locations

Investigative Site

Jamaica Plain, United States, 2130

Status
Completed
Locations

Investigative Site

New York, United States, 10016

Status
Completed
Locations

Investigative Site

Bangor, United States, 4401

Status
Completed
Locations

Investigative Site

Toronto, Canada, M5G 2M9

Status
Completed
Locations

Investigative Site

London, Canada, N6A 4L6

Status
Completed
Locations

Investigative Site

Toronto, Canada, M4N 3M5

Status
Completed
Locations

Investigative Site

Edmonton, Canada, T6G 1Z2

Status
Completed
Locations

Investigative Site

Hamilton, Canada, L8V 5C2

Status
Completed
Locations

Investigative Site

Halifax, Canada, B3H 2Y9

Status
Completed
Locations

Investigative Site

Winnipeg, Canada, R3E 0V9

Status
Completed
Locations

Investigative Site

Richmond, United States, 23230

Status
Completed
Locations

Investigative Site

Canton, United States, 44718 

Status
Completed
Locations

Investigative Site

Little Rock, United States, 72205

Status
Completed
Locations

Investigative Site

Lebanon, United States, 03766

Status
Completed
Locations

Investigative Site

Hartford, United States, 06105

Status
Completed
Locations

Investigative Site

Metairie, United States, 70006

Status
Completed
Locations

Investigative Site

Atlanta, United States, 30309

Status
Completed
Locations

Investigative Site

Augusta, United States, 30901

Status
Completed
Locations

Investigative Site

Orlando, United States, 32806

Status
Completed
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Investigative Site

Beverly, United States, 90211

Status
Completed
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Investigative Site

Ormond Beach, United States, 32174

Status
Completed
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Investigative Site

Macon, United States, 31201

Status
Completed
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Investigative Site

Ocala, United States, 34474

Status
Completed
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Investigative Site

Latham, United States, 12110

Status
Completed
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Investigative Site

Wynnewood, United States, 19096

Status
Completed
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Investigative Site

Pine Bluff, United States, 71603

Status
Completed
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Investigative Site

Glendale, United States, 85304

Status
Completed
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Investigative Site

Stamford, United States, 06902

Status
Completed
Locations

Investigative Site

Mobile, United States, 36608

Status
Completed
Locations

Investigative Site

Houston, United States, 77024

Status
Completed
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Investigative Site

Annapolis, United States, 21401

Status
Completed
Locations

Investigative Site

Louisville, United States, 40292

Status
Completed
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Investigative Site

Portland, United States, 97213

Status
Completed
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Investigative Site

Middletown, United States, 06457

Status
Completed
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Investigative Site

Stanford, United States, 94305

Status
Completed
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Investigative Site

Bronx, United States, 10466

Status
Completed
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Investigative Site

Joliet, United States, 60432

Status
Completed
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Investigative Site

Portland, United States, 97239

Status
Completed
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Investigative Site

Decatur, United States, 62526

Status
Completed
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Investigative Site

Scarborough, United States, 04074

Status
Completed
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Investigative Site

Council Bluffs, United States, 51503

Status
Completed
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Investigative Site

East Syracuse, United States, 13057

Status
Completed
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Investigative Site

Fresh Meadows, United States, 11365

Status
Completed
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Investigative Site

Loveland, United States, 80538

Status
Completed
Locations

Investigative Site

Duarte, United States, 91010

Status
Completed
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Investigative Site

Springfield, United States, 1107

Status
Completed
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Investigative Site

Buffalo, United States, 14263

Status
Completed
Locations

Investigative Site

Dallas, United States, 75246

Status
Completed
Locations

Investigative Site

Philadelphia, United States, 19106

Status
Completed
Locations

Investigative Site

Sioux Falls, United States, 57104

Status
Completed
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Investigative Site

Kokomo, United States, 46902

Status
Completed
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Investigative Site

San Francisco, United States, 94115

Status
Completed
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Investigative Site

Ocoee, United States, 34761

Status
Completed
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Investigative Site

Lacey, United States, 98503

Status
Completed
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Investigative Site

Oklahoma City, United States, 73120

Status
Completed
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Investigative Site

Tulsa, United States, 74136

Status
Completed
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Investigative Site

Vancouver, United States, 98684

Status
Completed
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Investigative Site

Panama City, United States, 32405

Status
Completed
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Investigative Site

Richmond, United States, 23229

Status
Completed
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Investigative Site

Evansville, United States, 47715

Status
Completed
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Investigative Site

Louisville, United States, 40207

Status
Completed
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Investigative Site

Cedar Rapids, United States, 52403

Status
Completed
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Investigative Site

Hialeah, United States, 33016

Status
Completed
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Investigative Site

Valparaiso, United States, 46383

Status
Completed
Locations

Investigative Site

Coeur D Alene, United States, 83814

Status
Completed
Locations

Investigative Site

Johnson City, United States, 13790

Status
Completed
Locations

Investigative Site

Morgantown, United States, 26505

Status
Completed
Locations

Investigative Site

Ames, United States, 50010

Status
Completed
Locations

Investigative Site

Boston, United States, 02215

Status
Completed
Locations

Investigative Site

Tacoma, United States, 98405

Status
Completed
Locations

Investigative Site

St Louis, United States, 63141

Status
Completed
Locations

Investigative Site

Norfolk, United States, 23502 

Status
Completed
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Investigative Site

Niles, United States, 60714

Status
Completed
Locations

Investigative Site

Louisville, United States, 40215

Status
Completed
Locations

Investigative Site

Austin, United States, 78731

Status
Completed
Locations

Investigative Site

Glendale, United States, 91206

Status
Completed
Locations

Investigative Site

Pollocksville, United States, 28573

Status
Completed
Locations

Investigative Site

Mount Kisco, United States, 10549

Status
Completed
Locations

Investigative Site

Austin, United States, 78759

Status
Completed
Locations

Investigative Site

Grand Rapids, United States, 49546

Status
Completed
Locations

Investigative Site

Lemoyne, United States, 17043

Status
Completed
Locations

Investigative Site

Fishers, United States, 46038

Status
Completed
Locations

Investigative Site

Amarillo, United States, 79106

Status
Completed
Locations

Investigative Site

Southington, United States, 06489

Status
Completed
Locations

Investigative Site

Lafayette, United States, 70506

Status
Completed
Locations

Investigative Site

Wichita, United States, 67214

Status
Completed
Locations

Investigative Site

Harvey, United States, 60426

Status
Completed
Locations

Investigative Site

Tampa, United States, 33607

Status
Completed
Locations

Investigative Site

Milwaukee, United States, 53215

Status
Completed
Locations

Investigative Site

Medford, United States, 97504

Status
Completed
Locations

Investigative Site

Sioux City, United States, 51101

Status
Completed
Locations

Investigative Site

Charleston, United States, 29406

Status
Completed
Locations

Investigative Site

Willmar, United States, 56201

Status
Completed
Locations

Investigative Site

Atlanta, United States, 30342

Status
Completed
Locations

Investigative Site

Ft Lauderdale, United States, 33308

Status
Completed
Locations

Investigative Site

Florence, United States, 29501

Status
Completed
Locations

Investigative Site

New Britain, United States, 06050

Status
Completed
Locations

Investigative Site

Fairfax, United States, 22031

Status
Completed
Locations

Investigative Site

Santa Fe, United States, 87505

Status
Completed
Locations

Investigative Site

Midland, United States, 79701

Status
Completed
Locations

Investigative Site

Cincinnati, United States, 45236

Status
Completed
Locations

Investigative Site

Richmond, United States, 23235

Status
Completed
Locations

Investigative Site

Phillipsburg, United States, 08865

Status
Completed
Locations

Investigative Site

Los Angeles, United States, 90057

Status
Completed
Locations

Investigative Site

Joliet, United States, 60435

Status
Completed
Locations

Investigative Site

Long Branch, United States, 07740

Status
Completed
Locations

Investigative Site

Barberton, United States, 44203

Status
Completed
Locations

Investigative Site

Hickory, United States, 28602

Status
Completed
Locations

Investigative Site

Mineola, United States, 11501

Status
Completed
Locations

Investigative Site

Des Moines, United States, 50309

Status
Completed
Locations

Investigative Site

Jacksonville, United States, 32207

Status
Completed
Locations

Investigative Site

Denver, United States, 80218

Status
Completed
Locations

Investigative Site

Long Beach, United States, 90813

Status
Completed
Locations

Investigative Site

Ann Arbor, United States, 48106

Status
Completed
Locations

Investigative Site

Melbourne, United States, 32901

Status
Completed
Locations

Investigative Site

Sacramento, United States, 95823

Status
Completed
Locations

Investigative Site

Dunkirk, United States, 14048

Status
Completed
Locations

Investigative Site

Columbia, United States, 29210

Status
Completed
Locations

Investigative Site

Omaha, United States, 68122

Status
Completed
Locations

Investigative Site

Highland, United States, 92346

Status
Completed
Locations

Investigative Site

Bessemer, United States, 35023

Status
Completed
Locations

Investigative Site

Charlotte, United States, 28203

Status
Completed
Locations

Investigative Site

Overland Park, United States, 66210

Status
Completed
Locations

Investigative Site

Louisville, United States, 40202

Status
Completed
Locations

Investigative Site

Summit, United States, 07901

Status
Completed
Locations

Investigative Site

Shreveport, United States, 71105

Status
Completed
Locations

Investigative Site

Memphis, United States, 38104

Status
Completed
Locations

Investigative Site

Omaha, United States, 68114

Status
Completed
Locations

Investigative Site

Morristown, United States, 07962

Status
Completed
Locations

Investigative Site

Belleville, United States, 07109

Status
Completed
Locations

Investigative Site

Quincy, United States, 02169

Status
Completed
Locations

Investigative Site

Tyler, United States, 75702

Status
Completed
Locations

Investigative Site

Philadelphia, United States, 19104

Status
Completed
Locations

Investigative Site

Glenwood Springs, United States, 81601

Status
Completed
Locations

Investigative Site

Conway, United States, 72034

Status
Completed
Locations

Investigative Site

Richmond, United States, 23298

Status
Completed
Locations

Investigative Site

Kittanning, United States, 16201

Status
Completed
Locations

Investigative Site

Montclair, United States, 07042

Status
Completed
Locations

Investigative Site

San Antonio, United States, 78245

Status
Completed
Locations

Investigative Site

Norwich, United States, 06360

Status
Completed
Locations

Investigative Site

Bethesda, United States, 20817

Status
Completed
Locations

Investigative Site

Cleveland, United States, 44195

Status
Completed
Locations

Investigative Site

Los Angeles, United States, 90095

Status
Completed
Locations

Investigative Site

Trumbull, United States, 06611

Status
Completed
Locations

Investigative Site

Cranston, United States, 02920

Status
Completed
Locations

Investigative Site

North Platte, United States, 69103

Status
Completed
Locations

Investigative Site

Kansas City, United States, 64118

Status
Completed
Locations

Investigative Site

Omaha, United States, 68124

Status
Completed
Locations

Investigative Site

Allentown, United States, 18105

Status
Completed
Locations

Investigative Site

Yakima, United States, 98902

Status
Completed

Trial Design