check_circleStudy Completed

Cancer genomic profiling

Bayer Identifier:

21421

ClinicalTrials.gov Identifier:

NCT04607889

EudraCT Number:

Not Available

EU CT Number:

Not Available
A study to learn more about what Japanese patients with solid tumors think about taking medicine that is based on their genetic information

Trial purpose

Researchers are looking for a better way to treat people with solid tumors. One new way is called cancer genomic medicine. In cancer genomic medicine, doctors use tests to look at the genetic information in a solid tumor. These tests are called panel tests. The results of the panel tests help doctors to choose the best type of medicine to treat that tumor.

In this study, the researchers want to learn more about what a large number of patients with solid tumors think are the burden and benefits of taking panel tests. The researchers also want to know what doctors who treat patients with solid tumors think about panel tests.

The study will include about 650 men and women in Japan who are at least 20 years old. About 340 of the participants will be patients with solid tumors who are taking medicine to help treat their tumors. About 310 of the patients will be doctors who are treating patients with solid tumors.

There will be 3 parts in this study. Part 1 will include patients with solid tumors. Parts 2 and 3 will include patients with solid tumors and doctors who are treating patients with solid tumors. In each part, the patients and doctors will answer questions about what they think of panel tests. During Part 1, all of the patients will answer questions in a teleconference. Some of the patients and physicians in Part 2 will also answer questions in a teleconference. During Part 2 and Part 3, all of the patients and doctors will complete an online questionnaire.

Key Participants Requirements

Sex

All

Age

20 - N/A
  • Part 1:
    - Adult female or male patient
    - Diagnosis of a solid tumor
    - Patients familiar with panel tests to be defined as:
     -- Patients who have taken a panel test
     -- Patients who have not taken a panel test
     --- Patients who have tried or considered taking a panel test
     --- Patients who have been offered a panel test but refused
    - Signed informed consent
    - Is 20 years of age or older

    Part 2 and Part 3 (patients):
    - Female or male patient
    - Diagnosis of a solid tumor (lung, or one of rare tumors defined by National Cancer Center and MHLW: mouth and lip, ovary and fallopian tube, urinary tract, soft tissue sarcoma, neuroendocrine, glioma, oropharynx, salivary, testis, parathesis, teratoma, skin melanoma, small intestine, nasal, nasal sinus, skin appendages, mesothelioma, GIST, vaginal and vulvar, thymic, nasopharynx, bone sarcoma, anus, uterine carcinosarcoma, penile, extragonadal germ cell, embryonal carcinoma, mucosa melanoma, pineal, brain and CNS, eye, peripheral nerve, trachea, melanoma of uvea, meningioma, histocytic and dendritic cell, trophoblastic tumor of placenta, Kaposi sarcoma, middle ear)
    - Sees the doctor for cancer treatment on regular basis (at least once every three months)
    - Signed informed consent
    - Is 20 years of age or older

    Part 2 and Part 3 (physician):
    - Has prescribed anti-cancer drugs to patients with a solid tumor (lung or one of rare tumors defined by National Cancer Center and MHLW: mouth and lip, ovary and fallopian tube, urinary tract, soft tissue sarcoma, neuroendocrine, glioma, oropharynx, salivary, testis, parathesis, teratoma, skin melanoma, small intestine, nasal, nasal sinus, skin appendages, mesothelioma, GIST, vaginal and vulvar, thymic, nasopharynx, bone sarcoma, anus, uterine carcinosarcoma, penile, extragonadal germ cell, embryonal carcinoma, mucosa melanoma, pineal, brain and CNS, eye, peripheral nerve, trachea, melanoma of uvea, meningioma, histocytic and dendritic cell, trophoblastic tumor of placenta, Kaposi sarcoma, middle ear) in the last 3 months.
    - Signed informed consent
  • Part 1:
    - Non-Japanese speakers
    - Declaring to be too unwell to perform an interview

    Part2 and Part 3 (patients):
    - Non-Japanese speakers
    - Declaring to be too unwell to complete the survey
    - Participation in the pilot study

    Part 2 and Part 3 (physician):
    - Non-Japanese speakers

Trial summary

Enrollment Goal
605
Trial Dates
December 2020 - September 2022
Phase
N/A
Could I Receive a placebo
No
Products
Unspecified
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locationsMany locations, Japan

Primary Outcome

  • Best-Worst Scaling scores showing patient preferences for the attributes of the process of taking panel tests
    Respondents will choose “Best” or “Worst” for prepared questions.
    date_rangeTime Frame:
    Up to 25 minutes

Secondary Outcome

  • Best-Worst Scaling scores showing doctor preferences for the attributes of the process of taking panel tests
    Doctors will choose “Best” or “Worst” for prepared questions.
    date_rangeTime Frame:
    Up to 25 minutes
  • Ranking of Best-Worst scaling scores for patients and for doctors
    Attributes will be ranked based on the responses by patients and doctors.
    date_rangeTime Frame:
    Up to 25 minutes
  • Patient and doctor willingness to try/offer panel tests based on different hypothetical conditions of panel tests and drugs in cancer genomic medicine
    Willingness to try questions based on hypothetical conditions would enable the policy makers and thought leaders improve the clinical practice of cancer genomic medicine in a patient-centric way.
    date_rangeTime Frame:
    Up to 25 minutes

Trial design

Measurement of Patient Views on the attributes of Cancer Genomic Medicine in Japan (Patient View Study)
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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