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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:
ClinicalTrials.gov Identifier:
NCT01082757
First Posted: March 9, 2010
Last Update Posted: July 31, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Merck Quimica Argentina S.A.I.C
Information provided by (Responsible Party):
Merck KGaA
  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 ]

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 ]

Enrollment: 1524
Study Start Date: June 2009
Study Completion Date: August 2013
Primary Completion Date: August 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

Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01082757


Locations
Argentina
Htal Vicente Lopez
Vicente Lopez, Argentina
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

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01082757     History of Changes
Other Study ID Numbers: EMR62202-513
First Submitted: March 8, 2010
First Posted: March 9, 2010
Last Update Posted: July 31, 2014
Last Verified: July 2014

Keywords provided by Merck KGaA:
Colorectal neoplasms
metastasis
colorectal cancer

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