Prevalence of the Mutational Status of V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) in Metastatic Colorectal Cancer (mCRC) in Argentine Patients
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Prevalence of the Mutational Status of KRAS in mCRC in Argentine Patients|
- Mutational status of KRAS: study of codons 12 and 13 in exon 1 of KRAS gene [ Time Frame: Initial visit (Day 1) and subsequent visit till the end of the study ] [ Designated as safety issue: No ]
- Subject and tumour characteristics and their association with KRAS mutational status [ Time Frame: Initial visit (Day 1) and subsequent visit till the end of the study ] [ Designated as safety issue: No ]
|Study Start Date:||June 2009|
|Study Completion Date:||August 2013|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
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.
- To record the prevalence of KRAS mutations in the Argentine mCRC population.
- 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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01082757
|Htal Vicente Lopez|
|Vicente Lopez, Argentina|
|Study Director:||Medical Director||Merck Quimica Argentina S.A.I.C|