Status:
COMPLETED
A Retrospective Non Interventional Study on First Line Treatment for Patients With BRAFV600E Mutant Metastatic Colorectal Cancer (mCRC)
Lead Sponsor:
Pierre Fabre Medicament
Collaborating Sponsors:
Clinact
Conditions:
BRAF V600E Mutation Positive
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Brief Summary
The presence of a BRAFV600E mutation is considered a marker of poor prognosis in patients with mCRC, and findings from clinical trials have largely remained inconclusive regarding the efficacy of firs...
Detailed Description
This retrospective, multi-center longitudinal study on BRAFV600E mutant mCRC patients will be conducted in Europe to characterize the first-line treatment patterns. All BRAFV600E mutant patients havin...
Eligibility Criteria
Inclusion
- 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
- Initiated first-line treatment with drugs registered for mCRC in the respective country at the time of treatment between January 1st, 2016 and December 31st, 2018 (both days inclusive)
- Provision of informed consent or non-opposition to the patient (or next of kin, if applicable) for the use of data, according to local regulations
Exclusion
- Patients will be excluded from the study if they fulfil any of the following criteria:
- Patients with another concomitant cancer at the time of diagnosis\*
- Patients participating in interventional trials on investigational drugs at the time of initiation of first-line treatment
- Except for non-metastatic non-melanoma skin cancers, or in situ or benign neoplasms; a cancer will be considered concomitant if it occurs within 5 years of mCRC diagnosis.
Key Trial Info
Start Date :
April 12 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 12 2021
Estimated Enrollment :
274 Patients enrolled
Trial Details
Trial ID
NCT04317599
Start Date
April 12 2020
End Date
May 12 2021
Last Update
January 2 2026
Active Locations (34)
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1
Barmherzige Brüder Krankenhaus St. Veit/Glan.
Saint Veit/Glan, Austria
2
Medizinische Universität Wien
Vienna, Austria
3
Imelda VZW
Bonheiden, Belgium
4
AZ Klina
Brasschaat, Belgium