Actively Recruiting
A Multicenter, Retrospective, Observational Study on Treatment for Patients With BRAFV600E Mutant Metastatic Colorectal Cancer (mCRC)
Led by Fudan University · Updated on 2024-12-27
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a real-world, multicenter observational study to better understand metastatic colorectal cancer (mCRC) patients in China who have the BRAFV600E mutation. Previous studies showed that patients with this mutation tend to have shorter survival times compared to those without it, but data specific to Chinese patients on mutation rates, diagnosis, prognosis, and survival are limited. This study aims to fill those gaps by collecting detailed information on these aspects. The study will observe patients with the BRAFV600E mutation who started treatment for mCRC between October 1, 2020, and October 1, 2025. Treatments involved are those registered for mCRC at the participating centers, but this is a non-interventional study, meaning researchers will not assign treatments but will record existing treatment patterns and regimens. There are no experimental drugs or placebos involved. Participants will be monitored for various outcomes including progression-free survival over 6 months, overall survival over 24 months, and overall response rate at 6 months. Data will be collected retrospectively from multiple centers to capture treatment effectiveness and safety in real-world settings. The study is sponsored by Fudan University and is expected to continue through October 2026.
CONDITIONS
Brief Title
A Study on Treatment for Patients With BRAFV600E Mutant Metastatic Colorectal Cancer (mCRC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of histologically or cytologically confirmed colorectal cancer that is metastatic and unresectable
- Presence of BRAFV600E mutation in tumor tissue confirmed by a local assay
- Adults aged 18 years or older
You will not qualify if you...
- History of chronic inflammatory bowel disease, chronic diarrhea, or recurrent bowel obstruction
- Presence of symptomatic brain metastases
- Active clinical severe infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 years
Participants who undergo routine care are observed to collect data on treatment outcomes and disease progression.
Visits as per routine clinical care
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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