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Prevalence of the Mutational Status of KRAS in mCRC in Argentine Patients

22 Years
Open (Enrolling)
Colorectal Neoplasms

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Trial Information

Prevalence of the Mutational Status of KRAS in mCRC in Argentine Patients

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.


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).

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
investigatorĀ“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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Mutational status of KRAS: study of codons 12 and 13 in exon 1 of KRAS gene

Outcome Time Frame:

Initial visit (Day 1) and subsequent visit till the end of the study

Safety Issue:


Principal Investigator

Medical Director

Investigator Role:

Study Director

Investigator Affiliation:

Merck Quimica Argentina S.A.I.C


Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Study ID:




Start Date:

June 2009

Completion Date:

July 2013

Related Keywords:

  • Colorectal Neoplasms
  • Colorectal neoplasms
  • metastasis
  • colorectal cancer
  • Neoplasms
  • Colorectal Neoplasms