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A Study on Treatment for Patients With BRAFV600E Mutant Metastatic Colorectal Cancer (mCRC)

NCT ID: NCT06749015

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-01

Study Completion Date

2026-10-01

Brief Summary

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Previous studies have shown that BRAFV600E mutant mCRC patients have a shorter survival time than BRAF wild type mCRC patients. For Chinese patients, however, it remains unclear about the BRAF gene mutation rate, diagnosis, prognosis and survival data in people with BRAFV600E mutant mCRC .

This real-world, multicenter non-interventional study (NIS) will describe the mutation rate, treatment patterns, effectiveness and safety of current treatment regimens in BRAFV600E mutant mCRC patients in China.

Detailed Description

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Conditions

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Metastatic Colorectal Cancer BRAF V600 Mutation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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No interventional

All BRAFV600E mutant patients having initiated treatment for mCRC between 01 October, 2020 and 01 October, 2025 (both days inclusive) with drugs registered for mCRC in respective study center

Non interventional study

Intervention Type OTHER

Non interventional study

Interventions

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Non interventional study

Non interventional study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of histologically or cytologically confirmed CRC that is metastatic and unresectable
* Presence of BRAFV600E mutation in tumor tissue, as confirmed by a local assay

Exclusion Criteria

* patients with previous chronic inflammatory bowel disease, chronic diarrhea or recurrent bowel obstruction patients with symptomatic brain metastases active clinical severe infection
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Zhiyu Chen

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Zhiyu Chen, MD,PhD

Role: primary

Other Identifiers

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BRAFm-mCRC

Identifier Type: -

Identifier Source: org_study_id