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

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 Overview

• Status: Completed
• Conditions: Advanced or Recurrent Solid Tumor Harboring an NTRK Gene Fusion
• Intervention / Treatment: Other: No Drug

• Study Type: Observational
• Enrollment (Actual): 46621

Contacts and Locations

Study Locations

• Japan
  • Multiple Locations, Japan
    • Many locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with any solid tumor and genome profiling results

Description

Inclusion Criteria:

• Patients with any solid tumor and genome profiling results

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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)

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2023
• Primary Completion (Actual): September 28, 2023
• Study Completion (Actual): September 28, 2023

Study Registration Dates

• First Submitted: March 20, 2023
• First Submitted That Met QC Criteria: March 20, 2023
• First Posted (Actual): March 31, 2023

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 22415

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No