check_circleStudy Completed

Advanced or recurrent solid tumor harboring an NTRK gene fusion

Bayer Identifier:

22415

ClinicalTrials.gov Identifier:

NCT05793281

EudraCT Number:

Not Available

EU CT Number:

Not Available
An observational study to learn more about NTRK gene fusion positive in Solid Tumor in Japan

Trial purpose

This is an observational study in which data from the past of people with solid tumors harboring an NTRK gene fusion in Japan are studied. In observational studies, only observations are made without specified advice or interventions.
Advanced or recurrent solid tumor harboring an NTRK gene fusion is a rare type of solid cancer caused by specific changes in the genes called NTRK gene fusion, and which has spread to nearby tissues and/or lymph nodes or has returned. Due to this change in the gene, an altered protein known as a TRK fusion protein is made, which can cause cancer cells to grow and survive.
The main purpose of this study is to learn more about NTRK gene fusion in people in Japan. To do this, researchers will collect information on the number or percentage of Japanese people with NTRK gene fusion in any solid tumor.
The data will come from the national database called C-CAT. They will cover the period from June 2019 until January 2023.
Besides this data collection, no further tests or examinations are planned, and no visits are required in this study.

Key Participants Requirements

Sex

All

Age

NaN - N/A
  • - Patients with any solid tumor and genome profiling results
  • - None

Trial summary

Enrollment Goal
46621
Trial Dates
March 2023 - September 2023
Phase
N/A
Could I Receive a placebo
No
Products
Vitrakvi (Larotrectinib, BAY2757556)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Active, not recruiting
Many LocationsMany Locations, Japan

Primary Outcome

  • Prevalence of patients with NTRK gene fusions by patient characteristic categories, such as tumor types
    date_rangeTime Frame:
    Retrospective data analysis from June 2019 to the latest data available (planned end of February 2023)
  • Distribution of cancer types in patients with NTRK fusion positive among all, adult and pediatric
    date_rangeTime Frame:
    Retrospective data analysis from June 2019 to the latest data available (planned end of February 2023)

Trial design

A Retrospective Observational Study to Investigate the Prevalence of NTRK gene fusion positive in Solid Tumor in Japan
Trial Type
Observational
Intervention Type
Other
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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