Cancer Genomic ProfilingNCT04607889
A Study to Learn More About What Japanese Patients With Solid Tumors Think About Taking Medicine That is Based on Their Genetic Information
An observational study of Cancer Genomic Profiling, run by Bayer at 1 site in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cancer Genomic Profiling
- What is being tested?
- Survey
- How many people
- 605 participants
- Where
- 1 siteJapan
- Study dates
- 15 Dec 2020to 15 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Show all 19Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- Participation in the pilot study
- Part 2 and Part 3 (physician):
- Non-Japanese speakers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measurement of Patient Views on the Attributes of Cancer Genomic Medicine in Japan (Patient View Study)
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.
Read more
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.
- Conditions
- Cancer Genomic Profiling
- Being tested
- Survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Also called Interviews
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.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 - Attribute development | An elicitation phase to develop the list of attributes and levels based on literature review and telephone interviews with patients. Receives: Other: Survey | |
| Part 2 - Pilot study | 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. Receives: Other: Survey | |
| Part 3 - Main study | The main study, with a self-administered, online survey, to be completed by cancer patients and physicians. Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 25 minutes
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Up to 25 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start15 Dec 2020
- Primary completion1 Aug 2022
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer Genomic ProfilingStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 605 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04607889
- Sponsor's protocol ID
- 21421
- Status last verified
- Oct 2022
- First submitted
- 23 Oct 2020
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Suehara Y, Hasegawa K, Majima Y, Mita N, Barbier S, Bogoeva N, Kato S. Patient and physician preferences for cancer panel testing in Japan: a best-worst scaling study. BMJ Open. 2025 Aug 26;15(8):e097620. doi: 10.1136/bmjopen-2024-097620.
PubMed 40858382
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Patient Views on the Attributes of Cancer Genomic Medicine in Japan (Patient View Study)
- ClinicalTrials.gov ID
- NCT04607889
- Acronym / sponsor ID
- 21421
- Conditions
- Cancer Genomic Profiling
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 605 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 29 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1 - Attribute development | – | Other: SurveyAn elicitation phase to develop the list of attributes and levels based on literature review and telephone interviews with patients. |
| Part 2 - Pilot study | – | Other: SurveyA 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. |
| Part 3 - Main study | – | Other: SurveyThe main study, with a self-administered, online survey, to be completed by cancer patients and physicians. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (19 listed)
- Adult female or male patient
- Diagnosis of a solid tumor
- Patients familiar with panel tests to be defined as:
- Signed informed consent
- Is 20 years of age or older
Key exclusion criteria (9 listed)
- Non-Japanese speakers
- Declaring to be too unwell to perform an interview
- Non-Japanese speakers
- Declaring to be too unwell to complete the survey
- Participation in the pilot study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveyAlso: InterviewsInterviews 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. | Other | Part 1 - Attribute development, Part 2 - Pilot study, Part 3 - Main study |
Primary outcome
Best-Worst Scaling scores showing patient preferences for the attributes of the process of taking panel tests
Time frame: Up to 25 minutes
Respondents will choose "Best" or "Worst" for prepared questions.
3 secondary outcomes
Best-Worst Scaling scores showing doctor preferences for the attributes of the process of taking panel tests
Time frame: Up to 25 minutes
Ranking of Best-Worst scaling scores for patients and for 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
Time frame: Up to 25 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Derived from this study: PubMed 40858382Suehara Y, Hasegawa K, Majima Y, Mita N, Barbier S, Bogoeva N, Kato S. Patient and physician preferences for cancer panel testing in Japan: a best-worst scaling study. BMJ Open. 2025 Aug 26;15(8):e097620. doi: 10.1136/bmjopen-2024-097620.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Genomic Profiling, run by Bayer at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best-Worst Scaling scores showing patient preferences for the attributes of the process of taking panel tests (time frame: Up to 25 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04607889, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.