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

July 30, 2014 updated by: Merck KGaA, Darmstadt, Germany

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.

Study Overview

Status

Completed

Conditions

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).

Study Type

Observational

Enrollment (Actual)

1524

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Vicente Lopez, Argentina
        • Htal Vicente Lopez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Initial visit (Day 1) and subsequent visit till the end of the study

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Initial visit (Day 1) and subsequent visit till the end of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck KGaA, Darmstadt, Germany

Collaborators

Merck Quimica Argentina S.A.I.C

Investigators

  • Study Director: Medical Director, Merck Quimica Argentina S.A.I.C

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

March 8, 2010

First Submitted That Met QC Criteria

March 8, 2010

First Posted (Estimate)

March 9, 2010

Study Record Updates

Last Update Posted (Estimate)

July 31, 2014

Last Update Submitted That Met QC Criteria

July 30, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMR62202-513

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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