Trial Information

Prevalence of the Mutational Status of KRAS in mCRC in Argentine Patients

This is an observational, prospective, non-interventional, single arm, non-comparative, open
label, multi-centric, multi-stage study to record the prevalence of KRAS mutations in the
Argentine mCRC population. The study is planned to be conducted in 150 centres (50 in each
of 3 stages of four months each, enrolling 500 subjects in each stage). Total of subjects:
1500. Demographic information, complete medical history and tumour history related data will
be captured in the first visit and if any information is missing, then only another visit
will be scheduled. Data captured will be analysed and presented using statistical tools.

OBJECTIVES:

Primary objective:

- To record the prevalence of KRAS mutations in the Argentine mCRC population.

Secondary objective:

- To record and evaluate certain subject and tumour characteristics for association with
KRAS mutational status (country, gender, age, performance status, body mass index
(BMI), ethnic origin, personal and family history of malignancy, personal and family
history of familial polyposis coli, smoking status, exercise, diet, tumour
characteristics/location, site of origin of the tissue sample sent for KRAS testing,
first line therapy chosen).