Prevalence of the Mutational Status of V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) in Metastatic Colorectal Cancer (mCRC) in Argentine Patients

Completed

• Conditions: Colorectal Neoplasms

• Registration Number: NCT01082757
• Lead Sponsor: Merck KGaA, Darmstadt, Germany

Brief Summary

This observational, prospective, multicentric study is being conducted to record the prevalence of KRAS mutations in the Argentine mCRC population.

Detailed Description

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).

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2010-03-08
• Study First Submitted QC: 2010-03-08
• Study First Posted: 2010-03-09
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-30
• Last Update Posted: 2014-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1524

Inclusion Criteria

• Subjects who have signed written informed consent before any study-related procedure
• Subjects with histologically confirmed adenocarcinoma of the colon/ rectum, T1-4 N0-2 M1 or rT1-4 N0-2 M1
• Subjects with age above 21 years
• Subjects willing to provide information required by protocol
• No previous systemic treatment for mCRC

Exclusion Criteria

• Subjects with known pregnancy
• Subjects with previous systemic therapy for mCRC
• Subjects with active infection or any other serious condition which, in the investigator´s mind, may render the subject ineligible for the study
• Subjects with medical or psychological condition, which, in the opinion of the investigator, would not permit the subject to sign meaningful informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mutational status of KRAS: study of codons 12 and 13 in exon 1 of KRAS gene	Initial visit (Day 1) and subsequent visit till the end of the study

Secondary Outcome Measures

Name	Time	Method
Subject and tumour characteristics and their association with KRAS mutational status	Initial visit (Day 1) and subsequent visit till the end of the study

Trial Locations

Locations (1)

Htal Vicente Lopez; 🇦🇷 Vicente Lopez, Argentina