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

Colorectal Carcinoma Clinical Trial

— KRAS  

Official title:

Study of KRAS Mutation in 250 Cases of Colorectal Carcinoma and Study of the Incidence of the Disease in Martinique, From 2007 to 2009

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01151007
• Other study ID #: 10/E/11
• Status: Completed
• Phase: N/A
• First received: June 24, 2010
• Last updated: September 21, 2016
• Start date: July 2011
• Est. completion date: December 2011

Study information

• Verified date: September 2016
• Source: University Hospital Center of Martinique
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: December 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Carcinoma
• Colorectal Carcinoma
• Colorectal Neoplasms

Locations

Country	Name	City	State
France	Laboratoire de Virologie - CHU de Fort de France	Fort de France	Martinique

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Center of Martinique

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The incidence of the colorectal carcinoma	Estimate the incidence of the colorectal carcinoma in Martinique between 2007 and 2009.	4 months	No