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

NCT01082757 | Completed

• 1 other identifier: EMR62202-513
• Study Type: observational
• Target: 1,524
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Colorectal Neoplasms

Keywords

Colorectal neoplasms; metastasis; colorectal cancer

Outcome Measures

Primary Outcomes (1)

• Mutational status of KRAS: study of codons 12 and 13 in exon 1 of KRAS gene

  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

  Initial visit (Day 1) and subsequent visit till the end of the study

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead
• Merck Quimica Argentina S.A.I.C: collaborator

Study Sites (1)

Htal Vicente Lopez

Vicente López, Argentina

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

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

Study Officials

• Medical Director

  Merck Quimica Argentina S.A.I.C

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2010
• First Posted: March 9, 2010
• Study Start: June 1, 2009
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: July 31, 2014

Record last verified: 2014-07

Locations

AR (1)