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French Digestive Polyposis Cohorte Family Adenomatous Polyposis With APC and MYH Gene Mutations , Cowden's Disease With PTEN Gene Mutation, Peutz Jeghers Disease With STK 11 Gene Mutation ,juvénil Polyposis With SMAD 4 Gene Mutation , Serrated and Hyperplastic Polyposis

This study is currently recruiting participants.
Verified August 2016 by Jean Christophe Saurin, Hôpital Edouard Herriot
Sponsor:
ClinicalTrials.gov Identifier:
NCT01987518
First Posted: November 19, 2013
Last Update Posted: August 30, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Jean Christophe Saurin, Hôpital Edouard Herriot
  Purpose
French cohorte about polyposis digestive diseases

Condition Intervention
Quality of Life Other: Procedure surgery behavioral and genetic diagnosis Procedure: quality of life after different type of surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: French Digestive Polyposis Cohorte

Resource links provided by NLM:


Further study details as provided by Jean Christophe Saurin, Hôpital Edouard Herriot:

Primary Outcome Measures:
  • genetic diagnosis or over 50 polyps in the stomach in the duodenum or in the colon [ Time Frame: 10 years ]

Biospecimen Retention:   Samples With DNA
Genetic Diagnostic

Estimated Enrollment: 350
Study Start Date: January 2011
Estimated Study Completion Date: August 2017
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
digestive polyposis
Family adenomatous polyposis (APC or MYH genes) Peutz Jeghers Disease Cowden Disease Festooned Polyposis Juvenile Polyposis Hyperplastic Polyposis
Other: Procedure surgery behavioral and genetic diagnosis
Observational Study
Procedure: quality of life after different type of surgery

Detailed Description:
Family Adenomatous Polyposis APC and MYH Genes Peutz Jeghers Disease Cowden Disease Festooned polyposis Juvenile polyposis Hyperplastic polyposis
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 90 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Digestive Polyposis Cohort
Criteria

Inclusion Criteria:

  • APC Gene mutation
  • MYH Homozygote mutation
  • COWDEN Disease with PTEN gene mutation
  • Peutz Jeghers Disease with STK 11 gene mutation
  • Juvenile polyposis with SMAD 4 gene mutation

Exclusion Criteria:

  • heterozygote MYH Gene Mutation
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01987518


Locations
France
Hopital Edouard Herriot Recruiting
Lyon, Rhone Alpes, France, 69000
Contact: Saurin Jean Christophe, msd    (33)0472117572    jean-christophe.saurin@chu-lyon.fr   
Contact: Vinet Olivier, CRA    (33)0472110370    olivier.vinet@chu-lyon.fr   
Principal Investigator: jean christophe saurin, msd         
Sponsors and Collaborators
Hôpital Edouard Herriot
Investigators
Principal Investigator: jean christophe saurin, msd HEH Hospital
  More Information

Responsible Party: Jean Christophe Saurin, Principal Investigator, Hôpital Edouard Herriot
ClinicalTrials.gov Identifier: NCT01987518     History of Changes
Other Study ID Numbers: Peps Data Base
SISRA ( Other Identifier: SISRA )
First Submitted: November 12, 2013
First Posted: November 19, 2013
Last Update Posted: August 30, 2016
Last Verified: August 2016