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Colonoscopy by Videocapsuls Versus Standard Colonoscopy. Intra-Individual Comparison for the Subject With a Medium or High Risk of Colorectal Cancer.

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

No phase specified


Screening


Active


18 to 80


Other


BRD 06/12-L
NCT00436514

Trial Description

Summary

Colorectal cancer is one of the most frequent and it pronosis is still serious. In France, diagnosis and screening applicated in numerous deprtements, and now in a path of generalization to the all country, is based on combination of searching blood into bowel movements (Hemocult) for the screening of population with medium risk (age between 50 to 74 years old)and colonoscopy for the screening and diagnosis of pre-cancerous lesions for the patients with a high risk.Even if the efficiency of this strategy is proved, searching blood into the bowel movement by Hemocult is still imperfect (a lot of false negative). Colonoscopy is not an ideal tool for screening. Indeed, its acceptability is not perfect and it constitu an invasiv method, with complications, with a compulsory general anesthesia, implicating a high cost. The alternative of a screening method based on a non invasiv method is required.

Eligibility Criteria

Inclusion Criteria:

  • age between 18 and 80 years
  • patient able to give his informed consent
  • No colorectal, intestinal inflammatory, ischemic or evolving infectious pathologies
  • No signs of stenosis of small intestine or colon
  • No contraindication to anesthesia
  • No particpation to an other clinical study
  • Patient with and indication to colonoscopy for searching of a colorectal neoplasia during a screening program OR
  • Patient for who a endoscopic following is required because of familial cases or personnal cases of polypes or colorectal cancer

Exclusion Criteria:

  • Presence of symptoms evocating an occlusiv pathology
  • Recent complicated colic diverticulosis
  • No infomed consent
  • pregnancy or no use of efficient contraception treatment
  • Patient with a pace-maker or others internal medical electronic device
  • Evoluted nephric or cardic insufficiences
  • Hypersensibility to Fleet Phospho Soda (or one of the excipient), bisacodyl (or one of the excipient), motilium (or one of the excipient)
  • Presence of a prolactinome

Trial Contact Information

Trial Lead Organizations/Sponsors

CHR Hotel Dieu

Jean Paul Galmiche, MDStudy Director

Stanislas Chaussade, MDPrincipal Investigator

Marie-Georges Lapalus, MDPrincipal Investigator

Christophe Cellier, MDPrincipal Investigator

Denis Heresbach, MDPrincipal Investigator

Bernard Filoche, MDPrincipal Investigator

Vincent Maunoury, MDPrincipal Investigator

Gerard Gay, MDPrincipal Investigator

Thierry Barrioz, MDPrincipal Investigator

Emmanuel Ben Soussan, MDPrincipal Investigator

Dimitri Coumaros, MDPrincipal Investigator

Jean Paul Galmiche, MDPh: 0240083028
  Email: jeanpaul.galmiche@chu-nantes.fr

Sylvie Sacher-Huvelin, MDPh: 0240083070
  Email: sylvie.sacher@chu-nantes.fr

Trial Sites

France
  nantes
 CHR Hotel Dieu
 Sylvie Sacher-Huvelin, MD Ph: 0240082859
  Email: sylvie.sacherhuvelin@chu-nantes.fr

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00436514
Information obtained from ClinicalTrials.gov on May 27, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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