Biomarkers for Early Detection of Ovarian Cancer Using Uterine Lavage

Screening programs for high-grade ovarian carcinoma failed to reduce disease-specific mortality, since they do not offer early enough detection of the disease. Most cases of high grade ovarian cancer develop in the fallopian tubes, hence the universal recommendation for high-risk populations (e.g., BRCA1/2 mutation carriers) is to undergo risk-reducing bilateral salpingo-oophorectomy (RRBSO) around the age of 40. The aims of this trial are: (1) to identify novel early-stage disease biomarkers using liquid biopsies obtained through uterine lavage, and (2) to optimize the technique a of uterine lavage and the processing of the samples for ultimate implementation as a routine diagnostic test for high risk populations.

Sex

Female

Minimum age

18 Years

Maximum age

80 Years

Inclusion Criteria:

* Subject must be at least 18 years of age.
* Subject must have all gynecological organs, including: vagina, cervix, uterus, fallopian tubes and ovaries.
* For the proof-of-principle cohort:

  * Subject must have been evaluated for a gynecologic condition, for which the treating physician has determined that a surgical intervention is required. The surgical procedure may be either: hysterectomy, surgical hysteroscopy, or salpingo-oophorectomy.
  * The eligible gynecological diagnoses include: high grade ovarian, fallopian tube or primary peritoneal carcinoma, or any non-malignant gynecologic condition.
* For the high risk cohort:

  * Subject must have an increased risk for developing ovarian cancer, as determined by genetic testing for BRCA1 or BRCA2 mutations, or by family history of at least one first degree relative that has been diagnosed with high grade ovarian cancer.

Exclusion Criteria:

* Subject is pregnant or is currently attempting to conceive.
* Subject has undergone resection of the uterus, fallopian tubes or ovaries.
* Subject is unable to read, understand and sign the informed consent form.
* Subject refuses to allow access to medical records or pathology reports.

• DERIVEDBahar-Shany K, Barnabas GD, Deutsch L, Deutsch N, Glick-Saar E, Dominissini D, Sapoznik S, Helpman L, Perri T, Blecher A, Katz G, Yagel I, Rosenblatt O, Shai D, Brandt B, Meyer R, Mohr-Sasson A, Volodarsky-Perel A, Zilberman I, Armon S, Jakobson-Setton A, Eitan R, Kadan Y, Beiner M, Josephy D, Brodsky M, Friedman E, Anafi L, Molchanov Y, Korach J, Geiger T, Levanon K. Proteomic signature for detection of high-grade ovarian cancer in germline BRCA mutation carriers. Int J Cancer. 2023 Feb 15;152(4):781-793. doi: 10.1002/ijc.34318. Epub 2022 Oct 23. PMID 36214786