KRAS Mutation and Incidence of the Colorectal Carcinoma in Martinique Between 2007 and 2009

NCT01151007 | Completed DMC

• 1 other identifier: 10/E/11
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

• There is no data at present concerning the KRAS mutation in patients from Martinique with colorectal cancer. Despite the fact that the incidence of this disease continues to increase there is no recent data to confirm it. This study has a descriptive purpose, allowing a comparison of the population from Martinique to other populations.
• A study of incidence of colorectal cancer, overseen by the Association from Martinique for the Epidemiological Search on Cancer (AMREC), also leads to a better knowledge of the local characteristics of the colorectal cancer.
• These two descriptive characteristics of colorectal cancer in Martinique will be useful data for the health professionals to provide their patients better care.

Conditions

Colorectal Carcinoma

Keywords

Kras mutation; colorectal carcinoma; Martinique

Outcome Measures

Primary Outcomes (1)

• Frequency of KRAS mutation

  Estimate the frequency of the KRAS mutation detected in paraffin embedded blocks of colorectal carcinoma operated in Martinique between 2007 and 2009

  4 months

Secondary Outcomes (1)

• The incidence of the colorectal carcinoma

  4 months

Study Arms (1)

Patients with colorectal carcinoma

Patient with colorectal carcinoma operated in Martinique between January 1st, 2007 and December 31st, 2009

Eligibility Criteria

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

Study Population

Patients who lived in martinique (a french west-indies island) with a colorectal carcinoma diagnosed between january 1st, 2007 and december 31st, 2009

You may qualify if:

• for the study of the KRAS mutation: 250 patients drawn by lots among the cases of colorectal carcinoma diagnosed between January 1st, 2007 and December 31st, 2009 in Martinique
• for the study of incidence: patient for whom was diagnosed a colorectal carcinoma between January 1st, 2007 and December 31st, 2009
• patient unopposed and in free agreement to participate in this study
• patient having his main home in Martinique at the time of the diagnosis
• patient 18 years old and over

You may not qualify if:

• patient whose diagnosis is prior to 2007 and later in 2009
• patient having shown opposition to the participation in this study
• patient minor or under guardianship
• patient not having his main home in Martinique at the time of the diagnosis

Sponsors & Collaborators

• University Hospital Center of Martinique: lead

Study Sites (1)

Laboratoire de Virologie - CHU de Fort de France

Fort de France, Martinique, 97261, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Paraffin embedded block of colorectal carcinoma obtained after biopsy or surgery

MeSH Terms

Conditions

Colorectal Neoplasms

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

Study Officials

• Odile BERA, MD

  Laboratoire de virologie - Centre Hospitalier Universitaire de Fort de France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2010
• First Posted: June 25, 2010
• Study Start: July 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: December 1, 2011
• Last Updated: September 23, 2016

Record last verified: 2016-09

Locations

FR (1)