Trial record 4 of 5 for:    "cowden syndrome"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Hôpital Edouard Herriot.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Jean Christophe Saurin, Hôpital Edouard Herriot
ClinicalTrials.gov Identifier:
NCT01987518
First received: November 12, 2013
Last updated: November 19, 2013
Last verified: January 2011
  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 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 ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

Genetic Diagnostic


Estimated Enrollment: 350
Study Start Date: January 2011
Primary Completion Date: January 2013 (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

Ages Eligible for Study:   12 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: November 12, 2013
Last Updated: November 19, 2013
Health Authority: France: The Commission nationale de l’informatique et des libertés
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: French Data Protection Authority
France: Haute Autorité de Santé Transparency Commission
France: National Consultative Ethics Committee for Health and Life Sciences

ClinicalTrials.gov processed this record on August 20, 2014