NCT01987518

Brief Summary

French cohorte about polyposis digestive diseases

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

November 12, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 19, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

February 28, 2018

Status Verified

February 1, 2018

Enrollment Period

3.6 years

First QC Date

November 12, 2013

Last Update Submit

February 27, 2018

Conditions

Quality of Life

Outcome Measures

Primary Outcomes (1)

  • genetic diagnosis or over 50 polyps in the stomach in the duodenum or in the colon

    10 years

Study Arms (1)

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 diagnosisProcedure: quality of life after different type of surgery

Interventions

Procedure surgery behavioral and genetic diagnosisOTHER

Observational Study

digestive polyposis
quality of life after different type of surgeryPROCEDURE
digestive polyposis

Eligibility Criteria

Age12 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Digestive Polyposis Cohort

You may qualify if:

  • 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

You may not qualify if:

  • heterozygote MYH Gene Mutation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Edouard Herriot

Lyon, Auvergne-Rhône-Alpes, 69000, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Genetic Diagnostic

Study Officials

  • jean christophe saurin, msd

    HEH Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 12, 2013

First Posted

November 19, 2013

Study Start

January 1, 2011

Primary Completion

August 1, 2014

Study Completion

August 1, 2020

Last Updated

February 28, 2018

Record last verified: 2018-02

Locations

FR(1)