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Completed

NCT Number: NCT05793281

An Observational Study to Learn More About 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.

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.

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Key information

Conditions

Advanced or Recurrent Solid Tumor Harboring an NTRK Gene Fusion

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations

Multiple Locations, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with any solid tumor and genome profiling results

Exclusion criteria

  • None

Treatment and study plan

No drug

Other

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

Primary outcomes

  1. 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)

  2. 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)

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 31, 2023
Registry last updated
Oct 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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