Clinical trial NCT01082757: Prevalence of the Mutational Status of V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) in Metastatic Colorectal Cancer (mCRC) in Argentine Patients
Official title: Prevalence of the Mutational Status of KRAS in mCRC in Argentine Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Neoplasms
Keywords: Colorectal neoplasms
metastasis
colorectal cancer
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
Collaborators: name: Merck Quimica Argentina S.A.I.C
First posted: 2010-03-09
Enrollment: 1524
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with histologicaly confirmed metastatic adenocarcinoma of the colon/rectum in Argentina

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).

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

Primary outcomes:
measure: Mutational status of KRAS: study of codons 12 and 13 in exon 1 of KRAS gene
timeFrame: Initial visit (Day 1) and subsequent visit till the end of the study
Secondary outcomes:
measure: Subject and tumour characteristics and their association with KRAS mutational status
timeFrame: Initial visit (Day 1) and subsequent visit till the end of the study
Other outcomes:
Locations:
city: Vicente Lopez
country: Argentina
facility: Htal Vicente Lopez
Study officials:
affiliation: Merck Quimica Argentina S.A.I.C
name: Medical Director
role: STUDY_DIRECTOR
References: