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

Completed

• Conditions: Advanced or Recurrent Solid Tumor Harboring an NTRK Gene Fusion
• Interventions: Other: No Drug

• Registration Number: NCT05793281
• Lead Sponsor: Bayer

Brief 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.

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

Not available

Study Timeline

• Study Start: 2023-03-10
• Study First Submitted: 2023-03-20
• Study First Submitted QC: 2023-03-20
• Study First Posted: 2023-03-31
• Primary Completion: 2023-09-28
• Study Completion: 2023-09-28
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-23
• Last Update Posted: 2023-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46621

Inclusion Criteria

• Patients with any solid tumor and genome profiling results

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with solid tumor and genome profiling results	No Drug	Retrospective data analysis, the dataset for this study will be extracted from the C-CAT database.

Primary Outcome Measures

Name	Time	Method
Distribution of cancer types in patients with NTRK fusion positive among all, adult and pediatric	Retrospective data analysis from June 2019 to the latest data available (planned end of February 2023)
Prevalence of patients with NTRK gene fusions by patient characteristic categories, such as tumor types	Retrospective data analysis from June 2019 to the latest data available (planned end of February 2023)

Trial Locations

Locations (1)

Many Locations; 🇯🇵 Multiple Locations, Japan