BRAF V600 Mutation, Metastatic Colorectal Cancer
Conditions
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.
Interventions
OTHERNon interventional study
Non interventional study
Sponsors
Fudan University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) | 6 months | the length of time between initiation of any line treatment for mCRC and the first documented disease progression |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | 24 months | length of time between any treatment initiation (for mCRC) and death (due to any cause) |
| Overall Response rate (ORR) | 6 months | number of complete response (CR) or partial response (PR) |
Countries
China
Outcome results
None listed