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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00224601 |
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Date of registration:
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16/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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CHROENDOHNPCC: Early Detection of Pre-cancer Lesions in Adults With Hereditary Nonpolyposis Colorectal Cancer Syndrome
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Scientific title:
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Early Detection of Pre-cancer Lesions in Adults With Hereditary Nonpolyposis Colorectal Cancer (HNPCC) Syndrome: Assessment of Coloscopy With Chromoscopy Benefit |
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Date of first enrolment:
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July 2005 |
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Target sample size:
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80 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00224601 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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Phase:
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Phase 2
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Countries of recruitment
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France
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Contacts
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Name:
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Christophe CELLIER, Pr,MD,PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Assistance Publique - Hôpitaux de Paris |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with MLH1, MSH2 or MSH6 mutation.
- Patients concerned by early detection colonoscopy.
Exclusion Criteria:
- Coloscopy of tracking since less 1an
- occlusive Syndrome contra-indicating the preparation for a total coloscopies
- Colectomies
- medical Conditions or serious illnesses contra-indicating a coloscopy of screening
- pregnant Woman or nursing
- Anomaly of coagulation contra-indicating the realization of biopsies and/or the
exeresis of the lesion colorectal
Age minimum:
25 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Colorectal Neoplasms, Hereditary Nonpolyposis
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Intervention(s)
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Procedure: Colonoscopy with chromoscopy
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Primary Outcome(s)
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Number of pre-cancer lesions or early cancer detected.
[Time Frame: during the procedure]
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Secondary Outcome(s)
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Anatomopathologic criteria (size of lesions, …).
[Time Frame: during the procedure]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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