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

• Sponsor: Bayer (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05793281
• Collaborator: (none)
• Enrollment: 50,000
• Location: 1
• Anticipated Duration (Months): 3
• Patients Per Site Per Month: 16723.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced or Recurrent Solid Tumor Harboring an NTRK Gene Fusion	Other: No Drug

Study Design

• Study Type: Observational
• Anticipated Enrollment: 50000 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: A Retrospective Observational Study to Investigate the Prevalence of NTRK Gene Fusion Positive in Solid Tumor in Japan
• Anticipated Study Start Date: Mar 31, 2023
• Anticipated Primary Completion Date: Jun 30, 2023
• Anticipated Study Completion Date: Jun 30, 2023

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. 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)]

2. 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)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with any solid tumor and genome profiling results

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Many Locations	Multiple Locations		Japan

Sponsors and Collaborators

• Bayer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• 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.

Publications

None provided.

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT05793281
• Other Study ID Numbers: 22415
• First Posted: Mar 31, 2023
• Last Update Posted: Mar 31, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasms

Study Results

No Results Posted as of Mar 31, 2023