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
Recruitment status was Not yet recruiting
Sponsor:
Centre Hospitalier Universitaire de Fort-de-France
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
| Tracking Information | |||||||||
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| First Received Date ICMJE | June 24, 2010 | ||||||||
| Last Updated Date | June 25, 2010 | ||||||||
| Start Date ICMJE | July 2010 | ||||||||
| Estimated Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01151007 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | KRAS Mutation and Incidence of the Colorectal Carcinoma in Martinique Between 2007 and 2009 | ||||||||
| Official Title ICMJE | Study of KRAS Mutation in 250 Cases of Colorectal Carcinoma and Study of the Incidence of the Disease in Martinique, From 2007 to 2009 | ||||||||
| Brief Summary |
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| Detailed Description |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: Paraffin embedded block of colorectal carcinoma obtained after biopsy or surgery |
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| 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 |
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| Condition ICMJE | Colorectal Carcinoma | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | Patients with colorectal carcinoma
Patient with colorectal carcinoma operated in Martinique between January 1st, 2007 and December 31st, 2009 |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 250 | ||||||||
| Estimated Completion Date | October 2010 | ||||||||
| Estimated Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01151007 | ||||||||
| Other Study ID Numbers ICMJE | 10/E/11 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Daniel RIAM- General director, Centre Hospitalier Universitaire de Fort-de-France | ||||||||
| Study Sponsor ICMJE | Centre Hospitalier Universitaire de Fort-de-France | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Centre Hospitalier Universitaire de Fort-de-France | ||||||||
| Verification Date | June 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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