Study Stopped
Cyber attack of the enrollment system, new system on going to be implemented
Cancer Risk Assessment in Patients With a Constitutional Alteration of the PTEN Gene
COCO
National Cohort of Patients With Cowden's Disease and With a Constitutional Alteration of the PTEN Gene for the Prospective Assessment of the Risk of Cancer.
1 other identifier
observational
430
1 country
45
Brief Summary
This is a multicentric, observational, retrospective and prospective study, aiming to estimate the risk of cancer occurrence in subjects carrying a PTEN mutation, based on the constitution of a national cohort.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2023
Longer than P75 for all trials
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2022
CompletedFirst Posted
Study publicly available on registry
November 29, 2022
CompletedStudy Start
First participant enrolled
June 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2048
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2048
May 15, 2026
May 1, 2026
24.6 years
November 10, 2022
May 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of subjects with a cancer event
Number of subjects with a cancer event (any cancer) observed in the population of subjects presenting a constitutional alteration of the PTEN gene.
From date of identification of a constitutional alteration of the PTEN gene until the date of first cancer event or date of death from any cause, whichever came first, assessed up to 20 years.
Secondary Outcomes (6)
Number of subjects with a breast cancer event
From date of identification of a constitutional alteration of the PTEN gene until the date of first breast cancer event or date of death from any cause, whichever came first, assessed up to 20 years.
Number of subjects with a thyroid cancer event
From date of identification of a constitutional alteration of the PTEN gene until the date of first thyroid cancer event or date of death from any cause, whichever came first, assessed up to 20 years.
Number of subjects with an endometrial cancer event
From date of identification of a constitutional alteration of the PTEN gene until the date of first endometrial cancer event or date of death from any cause, whichever came first, assessed up to 20 years.
Number of subjects with a renal cancer event
From date of identification of a constitutional alteration of the PTEN gene until the date of first renal cancer event or date of death from any cause, whichever came first, assessed up to 20 years.
Number of subjects with a colorectal cancer event
From date of identification of a constitutional alteration of the PTEN gene until the date of first colorectal cancer event or date of death from any cause, whichever came first, assessed up to 20 years.
- +1 more secondary outcomes
Eligibility Criteria
National observational cohort of participants identified as carriers of a constitutional alteration of the PTEN gene identified and/or confirmed by the Bergonié Institute, the national reference laboratory for the molecular diagnosis of Cowden's disease between 1997 and 2027.
You may qualify if:
- Male or female.
- Adult or child without age limit.
- Carrier of a constitutional or mosaic alteration of the PTEN gene established and/or confirmed by the Institut Bergonié's genetics laboratory, following a request for molecular diagnosis made between 1997 and 2027.
- Participant informed of his genetic diagnosis.
- Participant informed and not having expressed non-opposition to participate in the research.
- Participant affiliated to a French social security system in accordance with French law on research involving the human person.
You may not qualify if:
- Participant under guardianship or curatorship. Exception: a participant with autism may be included in the study.
- Persons deprived of their liberty by a judicial or administrative decision.
- Persons under psychiatric care, persons admitted to a health or social establishment for purposes other than research; Exception: a participant with autism may be included in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (45)
1-CHU Amiens
Amiens, France
2-CHU Angers
Angers, France
3-ICO Angers et Nantes
Angers, France
4-CHU Besançon
Besançon, France
5-CHU Bordeaux
Bordeaux, France
6-Institut Bergonié
Bordeaux, France
7-CHU Brest
Brest, France
8-Centre François Baclesse
Caen, France
9-CH Métropole Savoie Chambéry
Chambéry, France
10-CHU Colmar
Colmar, France
11-CHU Dijon
Dijon, France
12-CHU Grenoble
Grenoble, France
36-CH Le Mans
Le Mans, France
16-CHU Lille
Lille, France
17-CHU Limoges
Limoges, France
18a-Hospices Civils Lyon - Lyon Est
Lyon, France
18b-Hospices Civils Lyon - Lyon Sud
Lyon, France
19-AP-HM Hôpital de la Timone
Marseille, France
33-Institut Paoli Calmettes
Marseille, France
20-CHU Montpellier
Montpellier, France
21-CHU Nantes
Nantes, France
22-CHU Nice
Nice, France
32-Centre Antoine Lacassagne
Nice, France
37-CH Niort
Niort, France
23-CHU Nîmes
Nîmes, France
13a-AP-HP Hôpital Avicenne
Paris, France
13b-AP-HP Hôpital Saint-Antoine
Paris, France
13c-APH-HP Hôpital Salpétrière
Paris, France
13d-AP-HP Hôpital Trousseau
Paris, France
13e-AP-HP Hôpital Saint-Louis
Paris, France
13f-AP-HP Hôpital Robert Debré
Paris, France
14-Institut Curie
Paris, France
38-CHU Guadeloupe
Pointe à Pitre, France
24-CHU Poitiers
Poitiers, France
25-Institut du Cancer Courlancy
Reims, France
26-Centre Eugène Marquis
Rennes, France
27-CHU Rennes
Rennes, France
35-CHU Rouen
Rouen, France
28-CHU Saint-Etienne
Saint-Etienne, France
29-Institut Strauss
Strasbourg, France
30-CHU Toulouse
Toulouse, France
31-CHU Tours
Tours, France
40-CHU Troyes
Troyes, France
34-CH Valence
Valence, France
15-Institut Gustave Roussy
Villejuif, France
Study Officials
- PRINCIPAL INVESTIGATOR
Virginie BUBIEN, Dr
Institut Bergonié
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2022
First Posted
November 29, 2022
Study Start
June 12, 2023
Primary Completion (Estimated)
January 1, 2048
Study Completion (Estimated)
January 1, 2048
Last Updated
May 15, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share