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Trial record 2 of 5 for:    "Cowdens disease"

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

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ClinicalTrials.gov Identifier: NCT01987518
Recruitment Status : Recruiting
First Posted : November 19, 2013
Last Update Posted : August 30, 2016
Sponsor:
Information provided by (Responsible Party):
Jean Christophe Saurin, Hôpital Edouard Herriot

Brief Summary:
French cohorte about polyposis digestive diseases

Condition or disease Intervention/treatment
Quality of Life Other: Procedure surgery behavioral and genetic diagnosis 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

Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: French Digestive Polyposis Cohorte
Study Start Date : January 2011
Primary Completion Date : August 2014
Estimated Study Completion Date : August 2017


Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. 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


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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

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

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 Posted: November 19, 2013    Key Record Dates
Last Update Posted: August 30, 2016
Last Verified: August 2016