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Cyber attack of the enrollment system, new system on going to be implemented
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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.
After collection of the non objection and verification of the eligibility criteria, a first clinical questionnaire will be completed by the participant and the prescribing physician to collect the main medical events including the history of malignant tumor pathologies until the date of inclusion in the study.
Thereafter, an annual questionnaire will be sent to the participants to update the elements related to a tumor pathology.
For the case of patients who have died or been lost to follow-up, only the information from the first clinical questionnaire will be collected from the data available from the prescribing physician without informing the relatives. However, the investigating center will have to check that these patients have not objected, during their lifetime, to the use of their data.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with a breast cancer event | Number of subjects with a breast 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 breast cancer event or date of death from any cause, whichever came first, assessed up to 20 years. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Virginie BUBIEN, Dr | Institut Bergonié | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1-CHU Amiens | Amiens | France | ||||
| 2-CHU Angers |
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| Number of subjects with a thyroid cancer event | Number of subjects with a thyroid 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 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 | Number of subjects with an endometrial 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 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 | Number of subjects with a renal 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 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 | Number of subjects with a colorectal 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 colorectal cancer event or date of death from any cause, whichever came first, assessed up to 20 years. |
| Number of subjects with a melanoma cancer event | Number of subjects with a melanoma 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 melanoma cancer event or date of death from any cause, whichever came first, assessed up to 20 years. |
| 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 |