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Completed

NCT Number: NCT01082757

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

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Key information

Conditions

Colorectal Neoplasms Colonic Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Htal Vicente Lopez

Vicente López, Argentina

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Merck KGaA, Darmstadt, Germany

Industry

Collaborators

  • Merck Quimica Argentina S.A.I.C

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Mar 9, 2010
Registry last updated
Jul 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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