Advanced or Recurrent Solid Tumor Harboring an NTRK Gene FusionNCT05793281
An Observational Study to Learn More About NTRK Gene Fusion Positive in Solid Tumor in Japan
An observational study of Advanced or Recurrent Solid Tumor Harboring an NTRK Gene Fusion, run by Bayer at 1 site in Japan.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Advanced or Recurrent Solid Tumor Harboring an NTRK Gene Fusion
- What is being tested?
- No Drug
- How many people
- 46,621 participants
- Where
- 1 siteJapan
- Study dates
- 10 Mar 2023to 28 Sep 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with any solid tumor and genome profiling results
Who may be able to join
- Patients with any solid tumor and genome profiling results
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Observational Study to Investigate the Prevalence of NTRK Gene Fusion Positive in Solid Tumor in Japan
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.
Read more
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.
- Being tested
- No Drug
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No DrugOther
Retrospective data analysis, the dataset for this study will be extracted from the C-CAT database.
| Study group | Role | What they receive |
|---|---|---|
| Patients with solid tumor and genome profiling results | Retrospective data analysis, the dataset for this study will be extracted from the C-CAT database. Receives: Other: No Drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of patients with NTRK gene fusions by patient characteristic categories, such as tumor types
Measured: 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
Measured: Retrospective data analysis from June 2019 to the latest data available (planned end of February 2023)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start10 Mar 2023
- Primary completion28 Sep 2023
- Study completion28 Sep 2023
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 Advanced or Recurrent Solid Tumor Harboring an NTRK Gene FusionStudies 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
- Retrospective
- Enrolment
- 46,621 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05793281
- Sponsor's protocol ID
- 22415
- Status last verified
- Oct 2023
- First submitted
- 20 Mar 2023
- Last updated
- 25 Oct 2023
- 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.vivli.org 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 member section of the portal.
Publications
Nakata E, Osone T, Ogawa T, Taguchi T, Hattori K, Kohsaka S. Prevalence of neurotrophic tropomyosin receptor kinase (NTRK) fusion gene positivity in patients with solid tumors in Japan. Cancer Med. 2024 Jun;13(12):e7351. doi: 10.1002/cam4.7351.
PubMed 38925616
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Observational Study to Investigate the Prevalence of NTRK Gene Fusion Positive in Solid Tumor in Japan
- ClinicalTrials.gov ID
- NCT05793281
- Acronym / sponsor ID
- 22415
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46,621 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 28 Sep 2023 (actual)
- Study completion
- 28 Sep 2023 (actual)
- First posted
- 31 Mar 2023 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with solid tumor and genome profiling results | – | Other: No DrugRetrospective data analysis, the dataset for this study will be extracted from the C-CAT database. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with any solid tumor and genome profiling results
Key inclusion criteria (1 listed)
- Patients with any solid tumor and genome profiling results
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| No DrugRetrospective data analysis, the dataset for this study will be extracted from the C-CAT database. | Other | Patients with solid tumor and genome profiling results |
Primary outcome
Prevalence of patients with NTRK gene fusions by patient characteristic categories, such as tumor types
Time 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
Time frame: Retrospective data analysis from June 2019 to the latest data available (planned end of February 2023)
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 25 Oct 2023.
- Derived from this study: PubMed 38925616Nakata E, Osone T, Ogawa T, Taguchi T, Hattori K, Kohsaka S. Prevalence of neurotrophic tropomyosin receptor kinase (NTRK) fusion gene positivity in patients with solid tumors in Japan. Cancer Med. 2024 Jun;13(12):e7351. doi: 10.1002/cam4.7351.
- 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.vivli.org 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 member 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 Advanced or Recurrent Solid Tumor Harboring an NTRK Gene Fusion, 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 1 inclusion and 1 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 25 Oct 2023. 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?
Prevalence of patients with NTRK gene fusions by patient characteristic categories, such as tumor types (time frame: Retrospective data analysis from June 2019 to the latest data available (planned end of February 2023)). The study lists 2 primary outcomes in all. 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 NCT05793281, 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 25 Oct 2023.