An Observational Study to Learn More About NTRK Gene Fusion Positive in Solid Tumor in Japan

NCT ID: NCT05793281

Last Updated: 2023-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

46621 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-10

Study Completion Date

2023-09-28

Brief Summary

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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.

Detailed Description

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Conditions

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Advanced or Recurrent Solid Tumor Harboring an NTRK Gene Fusion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with solid tumor and genome profiling results

Retrospective data analysis, the dataset for this study will be extracted from the C-CAT database.

No Drug

Intervention Type OTHER

Retrospective data analysis, the dataset for this study will be extracted from the C-CAT database.

Interventions

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No Drug

Retrospective data analysis, the dataset for this study will be extracted from the C-CAT database.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with any solid tumor and genome profiling results

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Many Locations

Multiple Locations, , Japan

Site Status

Countries

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Japan

Related Links

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https://clinicaltrials.bayer.com/

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Other Identifiers

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22415

Identifier Type: -

Identifier Source: org_study_id

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