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

NCT ID: NCT01151007

Last Updated: 2016-09-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2011-12-31

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.

Detailed Description

• The colorectal carcinogenesis is complex. It influences among others, the EGFR (Epidermal Growth Factor Receptor) which activation leads to tumoral proliferation, differentiation and invasion. The binding of the EGF (Epidermal Growth Factor) or of another ligand to the EGFR is responsible for the activation of the Ras- Raf and Pi3k pathways.
• The mutation of the genes KRAS, BRAF or PIK3CA results in their continuous activation, independently of the activation or of the pharmacological blocking of EGFR. The most frequently found mutation affects the KRAS gene (20 to 50 % of the cases). 90 % of these mutations are situated on codons 12 and 13 of this gene (70 % codon 12 and 30 % codon 13). These mutations are responsible for a decrease of the GTPase activity of the ras protein, which stays then in active conformation bound to the GTP. This leads to the blocking of the pathway and to the inactivity of the pharmacological blocking of EGFR.

Conditions

Colorectal Carcinoma

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patients with colorectal carcinoma

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Center of Martinique

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Odile BERA, MD

Role: PRINCIPAL_INVESTIGATOR

Laboratoire de virologie - Centre Hospitalier Universitaire de Fort de France

Locations

Laboratoire de Virologie - CHU de Fort de France

Fort de France, Martinique, France

Countries

France

Other Identifiers

10/E/11

Identifier Type: -

Identifier Source: org_study_id