An observational study in Cancer Genomic Profiling, sponsored by Bayer. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2022-10-13.
Sponsored by Bayer · Observational
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.
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Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
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Part 1:
Adult female and male patients with a diagnosis of a solid tumor, who have taken or tried to take a panel test will be enrolled in the study.
Part 2 and Part 3 (patients):
Female and male patients with a diagnosis of a solid tumor and will be enrolled in the study.
Part 2 and Part 3 (physicians):
Physicians with experience in genomic medicine will be preferred as study participants but the sample will not be limited to them.
Part 1:
Patients familiar with panel tests to be defined as:
Patients who have not taken a panel test
Part 2 and Part 3 (patients):
Part 2 and Part 3 (physician):
Exclusion Criteria:
Part 1:
Part2 and Part 3 (patients):
Part 2 and Part 3 (physician):
An elicitation phase to develop the list of attributes and levels based on literature review and telephone interviews with patients.
Other: Survey
A pilot phase consisting of a self-administered, online survey, to be completed by patients and physicians, followed by telephone interviews with a subsample of participants.
Other: Survey
The main study, with a self-administered, online survey, to be completed by cancer patients and physicians.
Other: Survey
Interviews with study participants will be conducted by telephone or teleconference. The interview will focus on the participants experience with genomic tests, with the expectations, reasons for taking or declining it, hurdles encountered, satisfaction among the key themes to be discussed.
Also known as: Interviews
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.
Time frame: Up to 25 minutes
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.
Time 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.
Time 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.
Time frame: Up to 25 minutes
Plan to share: No — Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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