Biomarkers for Early Detection of Ovarian Cancer Using Uterine Lavage

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.

Conditions

• Ovarian Cancer
• Ovarian Carcinoma
• Fallopian Tube Cancer
• Primary Peritoneal Carcinoma
• Serous Cystadenocarcinoma

Interventions

PROCEDURE

Uterine lavage

Uterine lavage is performed using an intrauterine insemination catheter or rigid pipelle uterine sampler. The catheter is inserted into the cervical canal. 10mL of saline are infused into the uterine cavity and fallopian tubes and immediately retrieved.

PROCEDURE

Blood sample

5-10mL of blood will be drawn from participants.

DEVICE

Uterine lavage catheter

Uterine lavage is performed using an intrauterine insemination catheter or rigid pipelle uterine sampler. The catheter is inserted into the cervical canal. 10mL of saline are infused into the uterine cavity and fallopian tubes and immediately retrieved.

Sponsors & Collaborators

• Rabin Medical Center

  collaborator OTHER

• Meir Medical Center

  collaborator OTHER

• Shaare Zedek Medical Center

  collaborator OTHER

• Sheba Medical Center

  lead OTHER_GOV

Principal Investigators

• Keren Levanon, MD,PhD · Sheba Medical Center

• Yfat Kadan, MD · Meir Medical Center

• Ram Eitan, MD · Rabin Medical Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-06-29

Primary Completion

2022-12-31

Completion

2024-12-31

Countries

• Israel

Study Locations