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| ID | Type | Description | Link |
|---|---|---|---|
| PHRC-K11-106 | Other Grant/Funding Number | DGOS/INCA | |
| 2011-A01213-38 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| CTD-CNO | UNKNOWN |
| Laboratoire PRISM | UNKNOWN |
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Some BRCA-mutated women are reluctant to undergo laparoscopic bilateral salpingo-oophorectomy. The goal of the bilateral laparoscopic radical fimbriectomy the investigators suggest, is to suppress the tubal source of possible dysplastic cells from which can stem this high grade tumor, while preserving a natural ovarian hormonal secretion.
Most of ovarian carcinomas related to BRCA 1 or 2 mutations are of fallopian tube origin and especially from its distant part called the fimbria. These tubal, ovarian or primary peritoneal carcinomas are quite always of high grade serous type. They cannot be effectively screened due to the quickness of their evolution. In this context, a laparoscopic bilateral salpingo-oophorectomy (BSO) is the recommended prophylactic procedure.
Some BRCA-mutated women are reluctant to undergo this procedure considering the numerous adverse effects on body and quality of life, especially when hormonal replacement is forbidden. This refusal makes them at risk of developing a serous pelvic carcinoma.
The goal of the bilateral laparoscopic radical fimbriectomy the investigators suggest, is to suppress the tubal source of possible dysplastic cells from which can stem this high grade tumor, while preserving a natural ovarian hormonal secretion
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BRCA mutation carriers | Experimental | Women with BRCA1 or BRCA 2 mutation or a family history of breast/ovarian cancer. Radical fimbriectomy. Histopathology SEE-FIM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radical fimbriectomy | Procedure | Laparoscopic bilateral radical fimbriectomy : Complete resection of the tubes, from the uterine tube (up against the uterus) to the fimbriae, with resection of the part of the ovary adjacent to the ovarian fimbriae (adhering to the ovary) |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of pelvic cancer | Number of ovarian or primary serous peritoneal carcinoma occuring between fimbriectomy and menopause | an expected average of 15 years |
| Measure | Description | Time Frame |
|---|---|---|
| Morbidity associated with the radical prophylactic fimbriectomy | Morbidity will be assessed according to the Clavien-Dindo classification up to 30 days after the procedure and according to the NCI-CTCAE v4.0 grading scale beyond that time | Up to 30 days after the surgery |
| Rate of occult lesions on fimbriectomy specimens and secondary oophorectomy specimens |
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Inclusion Criteria:
Exclusion Criteria:
Bilateral oophorectomy without hysterectomy and amenorrhea more than 12 months and/or FSH> 20 UI/l History of hysterectomy and FSH> 20 UI/l
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| Name | Affiliation | Role |
|---|---|---|
| Carlos MARTINEZ-GOMEZ, MD | Centre Oscar Lambret | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Polyclinique du Parc Rambot | Aix-en-Provence | France | ||||
| Institut Bergonié |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37775701 | Result | Wisztorski M, Aboulouard S, Roussel L, Duhamel M, Saudemont P, Cardon T, Narducci F, Robin YM, Lemaire AS, Bertin D, Hajjaji N, Kobeissy F, Leblanc E, Fournier I, Salzet M. Fallopian tube lesions as potential precursors of early ovarian cancer: a comprehensive proteomic analysis. Cell Death Dis. 2023 Sep 30;14(9):644. doi: 10.1038/s41419-023-06165-5. | |
| 36831483 |
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| ID | Term |
|---|---|
| D061325 | Hereditary Breast and Ovarian Cancer Syndrome |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010051 | Ovarian Neoplasms |
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| Histopathology SEE-FIM | Other | Anatomopathological study of surgical specimens |
|
|
Number of serous tubal intraepithelial carcinoma or invasive carcinomas on the operative specimens |
| Within 1 month after fimbriectomy, and within 1 month after oophorectomy |
| Incidence of breast cancer on patients without breast cancer before fimbriectomy, and incidence (de novo or recurrence) of breast cancer on the overall study population | Number of cases of breast cancer or breast cancer recurrence observed | an expected average of 15 years |
| Rate of secondary oophorectomies and associated morbidity, and reasons for oophorectomy if decided before the age of 50 et before menopausis | Number of oophorectomies and time between fimbriectomy and oophorectomy Complications according to NCI-CTCAE v4.0 grading scale | an expected average of 15 years |
| Proteomic profile of tissues from radical fimbriectomy | Immunostaining is realised on sections of ovary portion, fimbriae and fallopian tubes, then tumoral zones are selected for spatially resolved gun microproteomic analysis | Up to 7 years after sample collection |
| Proportion of menopausal women before oophorectomy or at the LPLV without oophorectomy, and rate patients who experienced early menopause (before the age of 40) | Number of cases of menopausis an early menopausis observed | an expected average of 15 years |
| Proportion of benign histological abnormalities on radical Fimbriectomy specimens | Number of benign histological abnormalities on the operative specimens | Within 1 month after fimbriectomy |
| Patient's satisfaction at distance from Radical Fimbriectomy | Patient satisfaction survey | Up to 10 years |
| Bordeaux |
| France |
| Centre Jean Perrin | Clermont-Ferrand | France |
| Centre Oscar Lambret | Lille | France |
| CHR-U | Lille | France |
| Clinique du Bois - Bourgogne Center | Lille | France |
| Hospices Civils de Lyon | Lyon | France |
| Institut Paoli Calmettes | Marseille | France |
| Centre Antoine Lacassagne | Nice | France |
| Institut Curie | Paris | France |
| Centre Henri Becquerel | Rouen | France |
| IUCT-O Toulouse | Toulouse | France |
| Institut Gustave Roussy | Villejuif | France |
| Hôpital Privé VA | Villeneuve-d'Ascq | France |
| Leblanc E, Narducci F, Ferron G, Mailliez A, Charvolin JY, Houssein EH, Guyon F, Fourchotte V, Lambaudie E, Crouzet A, Fouche Y, Gouy S, Collinet P, Caquant F, Pomel C, Golfier F, Vaini-Cowen V, Fournier I, Salzet M, Tresch E, Probst A, Lemaire AS, Deley ML, Hudry D. Prophylactic Radical Fimbriectomy with Delayed Oophorectomy in Women with a High Risk of Developing an Ovarian Carcinoma: Results of a Prospective National Pilot Study. Cancers (Basel). 2023 Feb 10;15(4):1141. doi: 10.3390/cancers15041141. |
| D004701 |
| Endocrine Gland Neoplasms |
| D009386 | Neoplastic Syndromes, Hereditary |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |