Clinical Trial: Biomarkers for Early Detection of Ovarian Cancer Using Uterine Lavage

Study Status: Recruiting
Recruit Status: Recruiting
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

Brief 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.

Detailed Summary:

Brief 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.

The end point of the study is sensitivity and specificity of a liquid biopsy test based on uterine lavage for detection of ovarian cancer.

The study enrolls two cohorts:

  1. Proof-of-principle cohort - patients with either established ovarian cancer or other, non-malignant, gynecological conditions.
  2. High risk cohort - healthy women at genetically high-risk for ovarian cancer who have not undergone RRBSO.

Inclusion criteria include age over 18, ability to read, understand and sign informed consent form, and planned surgical procedure with general anesthesia (for the proof-of-principle cohort), or planned regular gynecological examination due to high-risk for developing ovarian cancer (high risk cohort).

Exclusion criteria include pregnancy or current attempts to conceive, any prior condition that precludes washing of the entire fallo
Sponsor: Sheba Medical Center

Current Primary Outcome: Ability of uterine lavage-based biomarkers to detect early stage ovarian cancer [ Time Frame: 7 years ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Complications rate of uterine lavage procedure in high risk population [ Time Frame: 7 years ]
    Assessment of complications rate based on patient's questionnaire and medical records
  • Burden of uterine lavage procedure as routine diagnostic test for high risk population [ Time Frame: 7 years ]
    Assessment of cost-effectiveness of uterine lavage-based diagnostic test for high risk population, including direct and indirect costs


Original Secondary Outcome: Same as current

Information By: Sheba Medical Center

Dates:
Date Received: May 3, 2017
Date Started: June 29, 2014
Date Completion: December 31, 2022
Last Updated: May 9, 2017
Last Verified: May 2017