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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Centre Hospitalier Universitaire de Fort-de-France.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Centre Hospitalier Universitaire de Fort-de-France
ClinicalTrials.gov Identifier:
NCT01151007
First received: June 24, 2010
Last updated: June 25, 2010
Last verified: June 2010

June 24, 2010
June 25, 2010
July 2010
October 2010   (final data collection date for primary outcome measure)
Frequency of KRAS mutation [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Estimate the frequency of the KRAS mutation detected in paraffin embedded blocks of colorectal carcinoma operated in Martinique between 2007 and 2009
Same as current
Complete list of historical versions of study NCT01151007 on ClinicalTrials.gov Archive Site
The incidence of the colorectal carcinoma [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Estimate the incidence of the colorectal carcinoma in Martinique between 2007 and 2009.
Same as current
Not Provided
Not Provided
 
KRAS Mutation and Incidence of the Colorectal Carcinoma in Martinique Between 2007 and 2009
Study of KRAS Mutation in 250 Cases of Colorectal Carcinoma and Study of the Incidence of the Disease in Martinique, From 2007 to 2009
  • 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.
  • 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.
Observational
Observational Model: Case-Only
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:

Paraffin embedded block of colorectal carcinoma obtained after biopsy or surgery

Probability Sample

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

Colorectal Carcinoma
Not Provided
Patients with colorectal carcinoma
Patient with colorectal carcinoma operated in Martinique between January 1st, 2007 and December 31st, 2009
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
250
October 2010
October 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Odile BERA, MD +596 596 552 412 odile.bera@chu-fortdefrance.fr
Contact: Véronique ERDUAL, Master +596 596 592 698 veronique.erdual@chu-fortdefrance.fr
France
 
NCT01151007
10/E/11
Yes
Daniel RIAM- General director, Centre Hospitalier Universitaire de Fort-de-France
Centre Hospitalier Universitaire de Fort-de-France
Not Provided
Principal Investigator: Odile BERA, MD Laboratoire de virologie - Centre Hospitalier Universitaire de Fort de France
Centre Hospitalier Universitaire de Fort-de-France
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP