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

A Retrospective Observational Study to Investigate the Prevalence of NTRK Gene Fusion Positive in Solid Tumor in Japan

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05793281

Enrollment

46621

Registered

2023-03-31

Start date

2023-03-10

Completion date

2023-09-28

Last updated

2023-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced or Recurrent Solid Tumor Harboring an NTRK Gene Fusion

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.

Interventions

OTHERNo Drug

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

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Patients with any solid tumor and genome profiling results

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame
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)
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)

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026