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CompletedNCT01151007KRASUpdated Sep 23, 2016

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

An observational study in Colorectal Carcinoma, sponsored by University Hospital Center of Martinique. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-23.

Sponsored by University Hospital Center of Martinique · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
250
Ages
18 Years and older
Sex
All
01

Study 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.
Read the 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.
02

Conditions studied

  • Colorectal Carcinoma

Keywords

  • Kras mutation
  • colorectal carcinoma
  • Martinique
03

In context

Carcinoma

6,745 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.

This study's enrollment of 250 is above the median of 149 across 1,175 observational studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

University Hospital Center of Martinique is the lead sponsor of 77 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

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

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
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
250 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • Patients with colorectal carcinoma

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

06

What researchers measure

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

    Time frame: 4 months

Secondary outcomes

  1. The incidence of the colorectal carcinoma

    Estimate the incidence of the colorectal carcinoma in Martinique between 2007 and 2009.

    Time frame: 4 months

07

Study locations

1 site
  • Laboratoire de Virologie - CHU de Fort de France
    Fort de France, Martinique 97261, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01151007
Lead sponsor
University Hospital Center of Martinique
Responsible party
Sponsor
First posted
Jun 25, 2010
Start date
Jul 2011
Primary completion
Oct 2011
Completion
Dec 2011
Last update
Sep 23, 2016

Study contacts

Odile BERA, MD
principal investigator · Laboratoire de virologie - Centre Hospitalier Universitaire de Fort de France

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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