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

This study is currently recruiting participants.
Verified February 2013 by Merck KGaA
Sponsor:
Collaborator:
Merck Quimica Argentina S.A.I.C
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01082757
First received: March 8, 2010
Last updated: February 11, 2013
Last verified: February 2013
  Purpose

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


Condition
Colorectal Neoplasms

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence of the Mutational Status of KRAS in mCRC in Argentine Patients

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • Mutational status of KRAS: study of codons 12 and 13 in exon 1 of KRAS gene [ Time Frame: Initial visit (Day 1) and subsequent visit till the end of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subject and tumour characteristics and their association with KRAS mutational status [ Time Frame: Initial visit (Day 1) and subsequent visit till the end of the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 1500
Study Start Date: June 2009
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   22 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects with histologicaly confirmed metastatic adenocarcinoma of the colon/rectum in Argentina

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01082757

Contacts
Contact: Medical Director +54 11 4546-8100 ext 8220

Locations
Argentina
Htal Vicente Lopez Recruiting
Vicente Lopez, Argentina
Contact: Gustavo Alberto Lopez, Doctor         
Principal Investigator: Gustavo Alberto Lopez         
Sponsors and Collaborators
Merck KGaA
Merck Quimica Argentina S.A.I.C
Investigators
Study Director: Medical Director Merck Quimica Argentina S.A.I.C
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01082757     History of Changes
Other Study ID Numbers: EMR62202-513
Study First Received: March 8, 2010
Last Updated: February 11, 2013
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Merck KGaA:
Colorectal neoplasms
metastasis
colorectal cancer

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on April 23, 2014