Recruiting

Ovarian Cancer Test

Sponsor:

Massachusetts General Hospital

Code:

NCT04794322

Conditions

Ovarian Neoplasms

Ovarian Epithelial Carcinoma

Fallopian Tube Neoplasms

High Grade Ovarian Serous Adenocarcinoma

Stage I Ovarian Cancer

Eligibility Criteria

Sex: Female

Age: 30+

Healthy Volunteers: Not accepted

Interventions

Uterine lavage, or a wash of the womb

Blood sample

Pap smear

Study Details

Brief summary:

The study aims to develop a test for early detection of ovarian cancer using DNA from a growth involving the ovary found in a washing of the uterus (womb), and proteins found in the blood. The samples of the wash and the blood will be taken before surgery. After surgery, doctors will determine whether the participant had ovarian cancer or a benign disease of the ovaries. The tests of the washings and the blood will be examined to see how much the participants with ovarian cancer can be separated from the participants with a benign ovarian disease by the tests. Small amounts from the washing and the blood samples will be sent to four sites for analysis.

Statistical analyses of these data will compare tumor DNA found in the washing of the uterus with proteins in the blood to detect cases of ovarian cancer. The primary goal is to find tests that are mostly positive for cases of ovarian cancer and mostly negative for patients with benign disease. It is hoped that if the tests work for participants with symptoms of the disease that these tests will also work when testing women who have no symptoms. A new study would be needed to see if the tests worked in this situation. If the tests work, this could lead to increasing the number of cases detected in early stage disease and decreasing the number of cases detected in late stage disease. If this change in late stage is large, it will likely reduce deaths due to ovarian cancer.

Conditions

Ovarian Neoplasms

Ovarian Epithelial Carcinoma

Fallopian Tube Neoplasms

High Grade Ovarian Serous Adenocarcinoma

Stage I Ovarian Cancer

Study ID

NCT04794322

Start date

Apr 13, 2020

Status verified date

Sep, 2025

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 30+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Has intact uterus (no history of uterine ablation, tubal ligation or bilateral salpingectomy)
  • Cohort 1 (n=200 participants): Women scheduled for surgery or diagnostic laparoscopy for suspected but undiagnosed ovarian/fallopian tube cancer
  • Cohort 2 (n=50 participants): Known BRCA1 or BRCA2 mutation carrier scheduled for risk-reducing salpingo-oophorectomy

Exclusion Criteria:

  • Current tissue or cytology diagnostic procedure positive for ovary cancer or any cancer
  • Inability to provide informed consent
  • Age less than 30 years
  • Inability to obtain the minimum amount of blood
  • Inability to obtain the minimum amount of uterine lavage sample
  • At risk if blood were drawn (e.g. hemophilia, serious anemia- Hb less than 8.0 gm/dL)
  • Prior history of known ovarian or endometrial cancer
  • Treatment less than 1 year (excluding hormonal therapy) for cancer that spread beyond its origin
  • History of untreated high-grade cervical dysplasia (CIN3)
  • History of treated high grade cervical dysplasia (CIN3) with a cytologically abnormal pap smear within the past year. If there is no post treatment Pap smear in the medical record, perform a Pap smear prior to the day of surgery. If this Pap smear is abnormal, the participant is ineligible.
  • Currently pregnant
  • Known Lynch syndrome

Study Design

Enrollment

250 participants

Anticipated

Interventions and Outcome Measures

Arms

Pelvic Mass Cohort (cohort #1)

200 participants scheduled for surgery for suspected ovarian cancer due to a pelvic mass but without a confirmed tissue or cytology diagnosis.

BRCA1/2 Carriers Cohort (cohort #2)

50 participants with an inherited BRCA1 or BRCA2 deleterious mutation without suspected ovarian cancers who are scheduled for risk-reducing salpingo-oophorectomy (RRSO) to remove ovaries and fallopian tubes.

Interventions

Uterine lavage, or a wash of the womb

Uterine lavage is performed during surgery using a flexible, 3-way balloon tipped catheter. The catheter is inserted through the cervix, the balloon expanded and the uterine cavity lavaged using 10 cc of sterile saline which is collected, processed and stored for later analysis.

Blood sample

Participants undergo two blood draws (one required, one optional) up to 31 days before surgery

Pap smear

Participants undergo a standard Papanicolaou smear to collect cells and fluid from the cervix.

Primary outcome measure

  • Genomic biomarkers assessing mutations and methylation of tumor DNA, and protein biomarkers measured as the concentration of a protein in pg/mL, both types of biomarkers measured in the collected biospecimens. [ Time Frame: From enrollment through to pathology results post-surgery (usually same day) ]

Central Contacts and Locations

Central contacts

Jackie Dahlgren

206 667 3438jdahlgre@fredhutch.org

Locations

University of Arkansas for Medical Sciences

Recruiting

Little Rock, Arkansas, United States, 72205

Contacts

Beth Scanlan

501-686-8274BScanlan@uams.edu

Principal Investigator:

Kristin Zorn, MD

Anne Arundel Health System

Recruiting

Annapolis, Maryland, United States, 21401

Contacts

Jaci Miller

443-481-5738jmiller9@aahs.org

Principal Investigator:

Monica Jones, MD

Johns Hopkins University School of Medicine

Recruiting

Baltimore, Maryland, United States, 21218

Contacts

Rebecca Stone, MD

rstone15@jhmi.edu

Principal Investigator:

Rebecca Stone, MD

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Tina Colella

617-643-5150tcolella@partners.org

Principal Investigator:

Amy Bregar, MD

The Swedish Hospital

Recruiting

Seattle, Washington, United States, 98122

Contacts

Robert Pearhill

206-667-3278rpearhil@fredhutch.org

Principal Investigator:

Charles Drescher, MD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Sep 16, 2025

Last verified

Sep, 2025

Keywords

  • Uterine Lavage
  • Tumor DNA
  • Serum proteins
  • Ovarian neoplasms
  • Ovarian epithelial carcinoma
  • Ovarian cancer
  • Ovarian epithelial cancer
  • Neoplasms
  • Ovarian diseases
  • Early detection

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-09-16.