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

NCT06749015 | Recruiting

• 1 other identifier: BRAFm-mCRC
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metastatic Colorectal Cancer; BRAF V600 Mutation

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

  the length of time between initiation of any line treatment for mCRC and the first documented disease progression

  6 months

Secondary Outcomes (2)

• Overall Survival (OS)

  24 months

• Overall Response rate (ORR)

  6 months

Study Arms (1)

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

Other: Non interventional study

Interventions

Non interventional study OTHER

Non interventional study

No interventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Diagnosis of histologically or cytologically confirmed mCRC with BRAFV600E mutation

You may qualify if:

• 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

You may not qualify if:

• patients with previous chronic inflammatory bowel disease, chronic diarrhea or recurrent bowel obstruction patients with symptomatic brain metastases active clinical severe infection

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: December 27, 2024
• Study Start: March 1, 2021
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)