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

Merck KGaA (EMD Serono)

Status: Completed

Conditions: Colorectal Neoplasms

Study type: Observational

Funder types: Industry

Identifiers

NCT01082757

EMR62202-513

Details and patient eligibility

About

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

Full 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).

Enrollment: 1,524 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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