NCT05793281

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46,621

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2023

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 31, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2023

Completed
Last Updated

October 25, 2023

Status Verified

October 1, 2023

Enrollment Period

7 months

First QC Date

March 20, 2023

Last Update Submit

October 23, 2023

Conditions

Advanced or Recurrent Solid Tumor Harboring an NTRK Gene Fusion

Outcome Measures

Primary Outcomes (2)

  • 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)

Study Arms (1)

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

Interventions

No DrugOTHER

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

Patients with solid tumor and genome profiling results

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with any solid tumor and genome profiling results

You may qualify if:

  • Patients with any solid tumor and genome profiling results

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Many Locations

Multiple Locations, Japan

Location

Related Links

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2023

First Posted

March 31, 2023

Study Start

March 10, 2023

Primary Completion

September 28, 2023

Study Completion

September 28, 2023

Last Updated

October 25, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

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.

Locations

JP(1)