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Biomarkers for Early Detection of Ovarian Cancer Using Uterine Lavage

NCT03150121UNKNOWNNAINTERVENTIONAL

Summary

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.

Key Facts

Lead Sponsor

Sheba Medical Center

Enrollment

500

Start Date

2014-06-29

Completion Date

2022-12-31

Study Type

INTERVENTIONAL

Official Title

Identification of Novel Biomarkers for Early Detection of Ovarian Cancer in High-risk and Normal-risk Populations Using Uterine Lavage

Interventions

Uterine lavageBlood sampleUterine lavage catheter

Conditions

Ovarian CancerOvarian CarcinomaFallopian Tube CancerPrimary Peritoneal CarcinomaSerous Cystadenocarcinoma

Eligibility

Age Range

18 Years – 80 Years

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

Ability of uterine lavage-based biomarkers to detect early stage ovarian cancer

Sensitivity and specificity of proteomic and genomic biomarkers measured in uterine lavage liquid biopsies. The samples will be analyzed in a blinded fashion. The pathological data of the patients will be reviewed and the sensitivity/specificity of each biomarker will be calculated

Time frame: 7 years

Secondary Outcomes

Complications rate of uterine lavage procedure in high risk population

Assessment of complications rate based on patient's questionnaire and medical records

Time frame: 7 years

Burden of uterine lavage procedure as routine diagnostic test for high risk population

Assessment of cost-effectiveness of uterine lavage-based diagnostic test for high risk population, including direct and indirect costs

Time frame: 7 years

Locations

Shaare Zedek Medical Center, Jerusalem, Israel

Meir Medical Center, Kfar Saba, Israel

Rabin Medical Center, Petah Tikva, Israel

Sheba Medical Center, Ramat Gan, Israel

Linked Papers

2022-10-23

Proteomic signature for detection of high‐grade ovarian cancer in germline BRCA mutation carriers

AbstractNo current screening methods for high‐grade ovarian cancer (HGOC) guarantee effective early detection for high‐risk women such as germline BRCA mutation carriers. Therefore, the standard‐of‐care remains risk‐reducing salpingo‐oophorectomy (RRSO) around age 40. Proximal liquid biopsy is a promising source of biomarkers, but sensitivity has not yet qualified for clinical implementation. We aimed to develop a proteomic assay based on proximal liquid biopsy, as a decision support tool for monitoring high‐risk population. Ninety Israeli BRCA1 or BRCA2 mutation carriers were included in the training set (17 HGOC patients and 73 asymptomatic women), (BEDOCA trial; ClinicalTrials.gov Identifier: NCT03150121). The proteome of the microvesicle fraction of the samples was profiled by mass spectrometry and a classifier was developed using logistic regression. An independent cohort of 98 BRCA mutation carriers was used for validation. Safety information was collected for all women who opted for uterine lavage in a clinic setting. We present a 7‐protein diagnostic signature, with AUC >0.97 and a negative predictive value (NPV) of 100% for detecting HGOC. The AUC of the biomarker in the independent validation set was >0.94 and the NPV >99%. The sampling procedure was clinically acceptable, with favorable pain scores and safety. We conclude that the acquisition of Müllerian tract proximal liquid biopsies in women at high‐risk for HGOC and the application of the BRCA‐specific diagnostic assay demonstrates high sensitivity, specificity, technical feasibility and safety. Similar classifier for an average‐risk population is warranted.

Linked Investigators

Keren Levanon