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

NCT ID: NCT01082757

Last Updated: 2014-07-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1524 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2013-08-31

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).

Conditions

Colorectal Neoplasms

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Quimica Argentina S.A.I.C

INDUSTRY

Sponsor Role: collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Quimica Argentina S.A.I.C

Locations

Htal Vicente Lopez

Vicente López, , Argentina

Countries

Argentina

Other Identifiers

EMR62202-513

Identifier Type: -

Identifier Source: org_study_id