Quality of LifeNCT01987518
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
An observational study of Quality of Life, run by Hôpital Edouard Herriot at 1 site in France.
Trial summary
French cohorte about polyposis digestive diseases Read more about this study
- Who is it for?
- Ages 12 to 90 years
- Conditions the study is for
- Quality of Life
- What is being tested?
- Procedure surgery behavioral and genetic diagnosis and quality of life after different type of surgery
- Type of treatment
- Surgery or procedure
- How many people
- 350 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2011to Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Digestive Polyposis Cohort
Who may be able to join
- 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
Who cannot join
- heterozygote MYH Gene Mutation
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hopital Edouard Herriot
Lyon, Auvergne-Rhône-Alpes, 69000
Saurin Jean Christophe, msd, (33)0472117572, jean-christophe.saurin@chu-lyon.fr
Vinet Olivier, CRA, (33)0472110370, olivier.vinet@chu-lyon.fr
About this study
Official title: French Digestive Polyposis Cohorte
French cohorte about polyposis digestive diseases
Read the detailed description
Family Adenomatous Polyposis APC and MYH Genes Peutz Jeghers Disease Cowden Disease Festooned polyposis Juvenile polyposis Hyperplastic polyposis
- Conditions
- Quality of Life
- Being tested
- Procedure surgery behavioral and genetic diagnosis, quality of life after different type of surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure surgery behavioral and genetic diagnosisOther
Observational Study
quality of life after different type of surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| digestive polyposis | Family adenomatous polyposis (APC or MYH genes) Peutz Jeghers Disease Cowden Disease Festooned Polyposis Juvenile Polyposis Hyperplastic Polyposis Receives: Other: Procedure surgery behavioral and genetic diagnosis; Procedure: quality of life after different type of surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
genetic diagnosis or over 50 polyps in the stomach in the duodenum or in the colon
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2013 (estimated)
- Study startJan 2011
- Primary completionAug 2014
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital Edouard Herriot
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean Christophe Saurin, Hôpital Edouard Herriot
- Investigators
- jean christophe saurin, msd, Principal investigator, HEH Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01987518
- Sponsor's protocol ID
- Peps Data Base
- Other IDs
- SISRA
- Status last verified
- Feb 2018
- First submitted
- 12 Nov 2013
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Le Bras P, Cauchin E, De Lange G, Moussata D, Garcia GA, Queneherve L, Saurin JC, Coron E. Impact of Endoscopic Treatment in Severe Duodenal Polyposis: A National Study in Familial Adenomatous Polyposis Patients. Clin Gastroenterol Hepatol. 2024 Sep;22(9):1839-1846.e1. doi: 10.1016/j.cgh.2024.03.007. Epub 2024 Mar 28.
PubMed 38555039
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French Digestive Polyposis Cohorte
- ClinicalTrials.gov ID
- NCT01987518
- Acronym / sponsor ID
- Peps Data Base
- Conditions
- Quality of Life
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Hôpital Edouard HerriotUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2020 (estimated)
- First posted
- 19 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
French cohorte about polyposis digestive diseases
Detailed description
Family Adenomatous Polyposis APC and MYH Genes Peutz Jeghers Disease Cowden Disease Festooned polyposis Juvenile polyposis Hyperplastic polyposis
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| digestive polyposis | – | Other: Procedure surgery behavioral and genetic diagnosis, Procedure: quality of life after different type of surgeryFamily adenomatous polyposis (APC or MYH genes) Peutz Jeghers Disease Cowden Disease Festooned Polyposis Juvenile Polyposis Hyperplastic Polyposis |
Who may qualify
- Ages
- 12 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Digestive Polyposis Cohort
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- heterozygote MYH Gene Mutation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Procedure surgery behavioral and genetic diagnosisObservational Study | Other | digestive polyposis |
| quality of life after different type of surgery | Procedure or surgery | digestive polyposis |
Primary outcome
genetic diagnosis or over 50 polyps in the stomach in the duodenum or in the colon
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
- Derived from this study: PubMed 38555039Le Bras P, Cauchin E, De Lange G, Moussata D, Garcia GA, Queneherve L, Saurin JC, Coron E. Impact of Endoscopic Treatment in Severe Duodenal Polyposis: A National Study in Familial Adenomatous Polyposis Patients. Clin Gastroenterol Hepatol. 2024 Sep;22(9):1839-1846.e1. doi: 10.1016/j.cgh.2024.03.007. Epub 2024 Mar 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
jean christophe saurin, msd principal investigator
HEH Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life, run by Hôpital Edouard Herriot at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
genetic diagnosis or over 50 polyps in the stomach in the duodenum or in the colon (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01987518, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2018.