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 has been completed.
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: July 30, 2014
Last verified: July 2014

March 8, 2010
July 30, 2014
June 2009
August 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01082757 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Prevalence of the Mutational Status of V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) in Metastatic Colorectal Cancer (mCRC) in Argentine Patients
Prevalence of the Mutational Status of KRAS in mCRC in Argentine Patients

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

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).
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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

Colorectal Neoplasms
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1524
August 2013
August 2013   (final data collection date for primary outcome measure)

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
Both
22 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Argentina
 
NCT01082757
EMR62202-513
Not Provided
Merck KGaA
Merck KGaA
Merck Quimica Argentina S.A.I.C
Study Director: Medical Director Merck Quimica Argentina S.A.I.C
Merck KGaA
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP