Developing a Test of Uterine Lavage for the Detection of Ovarian Cancer

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Massachusetts General Hospital
Study ID
NCT04794322
Status
Recruiting
Apply to this trial

Conditions

  • Fallopian Tube Neoplasms
  • High Grade Ovarian Serous Adenocarcinoma
  • Ovarian Epithelial Carcinoma
  • Ovarian Neoplasms
  • Stage I Ovarian Cancer
  • Stage II Ovarian Cancer
  • Stage III Ovarian Cancer AJCC v8
  • Stage IIIA Ovarian Cancer AJCC v8
  • Stage IIIA1 Ovarian Cancer AJCC v8
  • Stage IIIA2 Ovarian Cancer AJCC v8
  • Stage IIIB Ovarian Cancer AJCC v8
  • Stage IIIC Ovarian Cancer AJCC v8
  • Stage IV Ovarian Cancer AJCC v8
  • Stage IVA Ovarian Cancer AJCC v8
  • Stage IVB Ovarian Cancer AJCC v8

Eligibility Criteria

Sex
FEMALE
Age
30 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Uterine lavage, or a wash of the womb — DIAGNOSTIC_TEST
    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 — DIAGNOSTIC_TEST
    Participants undergo two blood draws (one required, one optional) up to 31 days before surgery
  • Pap smear — DIAGNOSTIC_TEST
    Participants undergo a standard Papanicolaou smear to collect cells and fluid from the cervix.

Study Details

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.

Key Dates

Start date
Apr 13, 2020
Status verified
Sep 2025
Primary completion
Aug 31, 2027
Completion
Aug 31, 2028

Study Design

Enrollment
250 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.

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

Locations (6)

FacilityCityStateZIPSite coordinators
University of Arkansas for Medical SciencesLittle RockArkansas72205
Beth Scanlan
[email protected]
501-686-8274
Kristin Zorn, MD (PRINCIPAL_INVESTIGATOR)
Kaiser Permanente - San FranciscoSan FranciscoCalifornia94115-
Anne Arundel Health SystemAnnapolisMaryland21401
Jaci Miller
[email protected]
443-481-5738
Monica Jones, MD (PRINCIPAL_INVESTIGATOR)
Johns Hopkins University School of MedicineBaltimoreMaryland21218
Rebecca Stone, MD
[email protected]
Rebecca Stone, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Tina Colella
[email protected]
617-643-5150
Amy Bregar, MD (PRINCIPAL_INVESTIGATOR)
The Swedish HospitalSeattleWashington98122
Robert Pearhill
[email protected]
206-667-3278
Charles Drescher, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Little Rock, AR

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
University of Arkansas for Medical Sciences· Little Rock, ARKaiser Permanente - San Francisco· San Francisco, CAAnne Arundel Health System· Annapolis, MDJohns Hopkins University School of Medicine· Baltimore, MDMassachusetts General Hospital· Boston, MAThe Swedish Hospital· Seattle, WA

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