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Radical Fimbriectomy for Young BRCA Mutation Carriers

NCT01608074Active, Not RecruitingNAINTERVENTIONAL

Summary

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.

Key Facts

Lead Sponsor

Centre Oscar Lambret

Enrollment

123

Start Date

2012-01-09

Completion Date

2033-08-01

Study Type

INTERVENTIONAL

Official Title

Radical Fimbriectomy for Young BRCA Mutation Carriers at Risk of Pelvic Serous Carcinoma

Interventions

Radical fimbriectomyHistopathology SEE-FIM

Conditions

BRCA1 MutationBRCA2 MutationHereditary Breast and Ovarian Cancer

Eligibility

Age Range

35 Years+

Sex

FEMALE

Inclusion Criteria:

* Woman aged over 35 years
* When project of childbearing is fulfilled
* With a BRCA 1 or 2 mutation, or a family history of breast/ovarian cancer
* Unprepared to undergo bilateral annexectomy
* With or without breast cancer
* Patient affiliated to health insurance
* Dated and signed informed consent

Exclusion Criteria:

* Menopausal woman defined as :

Bilateral oophorectomy without hysterectomy and amenorrhea more than 12 months and/or FSH\> 20 UI/l History of hysterectomy and FSH\> 20 UI/l

* Pregnant or breastfeeding woman

Outcome Measures

Primary Outcomes

Rate of pelvic cancer

Number of ovarian or primary serous peritoneal carcinoma occuring between fimbriectomy and menopause

Time frame: an expected average of 15 years

Secondary Outcomes

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

Time frame: Up to 30 days after the surgery

Rate of occult lesions on fimbriectomy specimens and secondary oophorectomy specimens

Number of serous tubal intraepithelial carcinoma or invasive carcinomas on the operative specimens

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: an expected average of 15 years

Proportion of benign histological abnormalities on radical Fimbriectomy specimens

Number of benign histological abnormalities on the operative specimens

Time frame: Within 1 month after fimbriectomy

Patient's satisfaction at distance from Radical Fimbriectomy

Patient satisfaction survey

Time frame: Up to 10 years

Locations

Polyclinique du Parc Rambot, Aix-en-Provence, France

Institut Bergonié, 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

Linked Papers

2023-09-30

Fallopian tube lesions as potential precursors of early ovarian cancer: a comprehensive proteomic analysis

Abstract Ovarian cancer is the leading cause of death from gynecologic cancer worldwide. High-grade serous carcinoma (HGSC) is the most common and deadliest subtype of ovarian cancer. While the origin of ovarian tumors is still debated, it has been suggested that HGSC originates from cells in the fallopian tube epithelium (FTE), specifically the epithelial cells in the region of the tubal-peritoneal junction. Three main lesions, p53 signatures, STILs, and STICs, have been defined based on the immunohistochemistry (IHC) pattern of p53 and Ki67 markers and the architectural alterations of the cells, using the Sectioning and Extensively Examining the Fimbriated End Protocol. In this study, we performed an in-depth proteomic analysis of these pre-neoplastic epithelial lesions guided by mass spectrometry imaging and IHC. We evaluated specific markers related to each preneoplastic lesion. The study identified specific lesion markers, such as CAVIN1, Emilin2, and FBLN5. We also used SpiderMass technology to perform a lipidomic analysis and identified the specific presence of specific lipids signature including dietary Fatty acids precursors in lesions. Our study provides new insights into the molecular mechanisms underlying the progression of ovarian cancer and confirms the fimbria origin of HGSC.

Linked Investigators

Firas Kobeissy

Isabelle Fournier

Prof. Fournier is a Distinguished Professor at the University of Lille and she holds a position as co-director of the PRISM Inserm U1192 Lab and as Vice President for Doctoral Research at the University of Lille. She is a bioanalytical chemist specialized in clinical mass spectrometry and proteomics. She started research working on the fundamentals of MALDI during her PhD at the University Pierre & Marie Curie in Paris first and then, as a postdoctoral fellow within the group of Prof. Michael Karas in Frankfurt. In 2002, she established her own group at the University of Lille where she started developing MALDI MS Imaging. She contributed to the field with several developments including strategies for imaging of FFPE tissues and proteins, and the development of tagged probes for specific imaging of mRNA and antigens. In 2009, she was hired as a Full Professor and awarded a Junior position at Institut Universitaire de France. Since 2012, she has been interested in the development of Spatially-Resolved Proteomics in combination with MALDI MSI for applications in oncology. Over the past 5 years, she also worked on the development of in vivo MS for guided surgery and intraoperative analysis. She confounded the Imabiotech Company which provides services in MALDI MSI. She was recently distinguished by the International Distinguish Award from MSACL and was awarded a senior position at Institut Universitaire de France.

Maxence Wisztorski

Specialist in Mass spectrometry and MS Imaging with a background in cell biology. Expert on MS-based proteomics and spatially resolved proteomics for cancer study.

Michel Salzet

Scientific Titles 1998-2003 Member of the Institut Universitaire de France Junior, then Honorary position 1998-2000 Senior Scientist at the Mind Body Institute of Harvard Medical School, USA 31/05/1995 Habilitation for directing research in Natural Sciences, University Lille 1 3/02/1993 PhD in Life Science and Heath, University Lille 1 Cursus 1993-1994 Post-doctoral fellows, Neurosciences Research Institute, Old Westbury, USA 1993 PhD Life Sciences and Health at the University of Lille 1991-1992 Pre-doctoral at Biopharm, Hendy, UK 1990 National Service, Aspirant, Medal of National Defense 1989 Master degree Science of Life and Health, University of Lille 1, Honors Current Situation 2009 Distinguished Professor University of Lille 1, Honorar Junior Member of Institut Universitaire de France 1998-Present Laboratory director

Soulaimane Aboulouard

Tristan Cardon