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

RecruitingOBSERVATIONAL
Enrollment

250

Participants

Timeline

Start Date

April 13, 2020

Primary Completion Date

August 31, 2027

Study Completion Date

August 31, 2028

Conditions
Ovarian NeoplasmsOvarian Epithelial CarcinomaFallopian Tube NeoplasmsHigh Grade Ovarian Serous AdenocarcinomaStage I Ovarian CancerStage II Ovarian CancerStage III Ovarian Cancer AJCC v8Stage IIIA Ovarian Cancer AJCC v8Stage IIIA1 Ovarian Cancer AJCC v8Stage IIIA2 Ovarian Cancer AJCC v8Stage IIIB Ovarian Cancer AJCC v8Stage IIIC Ovarian Cancer AJCC v8Stage IV Ovarian Cancer AJCC v8Stage IVA Ovarian Cancer AJCC v8Stage IVB Ovarian Cancer AJCC v8
Interventions
DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

Blood sample

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

DIAGNOSTIC_TEST

Pap smear

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

Trial Locations (6)

21218

RECRUITING

Johns Hopkins University School of Medicine, Baltimore

21401

RECRUITING

Anne Arundel Health System, Annapolis

72205

RECRUITING

University of Arkansas for Medical Sciences, Little Rock

94115

ACTIVE_NOT_RECRUITING

Kaiser Permanente - San Francisco, San Francisco

98122

RECRUITING

The Swedish Hospital, Seattle

02114

RECRUITING

Massachusetts General Hospital, Boston

All Listed Sponsors
collaborator

Johns Hopkins University

OTHER

collaborator

Fred Hutchinson Cancer Center

OTHER

collaborator

Anne Arundel Health System Research Institute

OTHER

collaborator

University of Arkansas

OTHER

collaborator

National Cancer Institute (NCI)

NIH

collaborator

Kaiser Permanente

OTHER

collaborator

McGill University

OTHER

collaborator

M.D. Anderson Cancer Center

OTHER

collaborator

Swedish Medical Center

OTHER

collaborator

Early Detection Research Network

NETWORK

lead

Massachusetts General Hospital

OTHER