- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01987518
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
February 27, 2018 updated by: Jean Christophe Saurin, Hôpital Edouard Herriot
French Digestive Polyposis Cohorte
French cohorte about polyposis digestive diseases
Study Overview
Status
Unknown
Conditions
Detailed Description
Family Adenomatous Polyposis APC and MYH Genes Peutz Jeghers Disease Cowden Disease Festooned polyposis Juvenile polyposis Hyperplastic polyposis
Study Type
Observational
Enrollment (Anticipated)
350
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rhone Alpes
-
Lyon, Rhone Alpes, France, 69000
- Recruiting
- Hôpital Edouard Herriot
-
Contact:
- Saurin Jean Christophe, msd
- Phone Number: (33)0472117572
- Email: jean-christophe.saurin@chu-lyon.fr
-
Contact:
- Vinet Olivier, CRA
- Phone Number: (33)0472110370
- Email: olivier.vinet@chu-lyon.fr
-
Principal Investigator:
- jean christophe saurin, msd
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 90 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Digestive Polyposis Cohort
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
digestive polyposis
Family adenomatous polyposis (APC or MYH genes) Peutz Jeghers Disease Cowden Disease Festooned Polyposis Juvenile Polyposis Hyperplastic Polyposis
|
Observational Study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
genetic diagnosis or over 50 polyps in the stomach in the duodenum or in the colon
Time Frame: 10 years
|
10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: jean christophe saurin, msd, HEH Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Actual)
August 1, 2014
Study Completion (Anticipated)
August 1, 2020
Study Registration Dates
First Submitted
November 12, 2013
First Submitted That Met QC Criteria
November 12, 2013
First Posted (Estimate)
November 19, 2013
Study Record Updates
Last Update Posted (Actual)
February 28, 2018
Last Update Submitted That Met QC Criteria
February 27, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- Peps Data Base
- SISRA (Other Identifier: SISRA)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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