Ovarian Cancer Detection by Uterine Lavage DNA and Serum Proteins: a Phase 2 Biomarker Study

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 30
Healthy Volunteers: f
View:

• 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

Locations
United States
Arkansas
University of Arkansas for Medical Sciences
RECRUITING
Little Rock
California
Kaiser Permanente - San Francisco
ACTIVE_NOT_RECRUITING
San Francisco
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Maryland
Anne Arundel Health System
RECRUITING
Annapolis
Johns Hopkins University School of Medicine
RECRUITING
Baltimore
Washington
The Swedish Hospital
RECRUITING
Seattle
Contact Information
Primary
Jackie Dahlgren
jdahlgre@fredhutch.org
206 667 3438
Time Frame
Start Date: 2020-04-13
Estimated Completion Date: 2028-08-31
Participants
Target number of participants: 250
Treatments
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.
Authors
Christine Garcia
Related Therapeutic Areas
Sponsors
Collaborators: Fred Hutchinson Cancer Center, Swedish Medical Center, McGill University, Anne Arundel Health System Research Institute, University of Arkansas, Johns Hopkins University, National Cancer Institute (NCI), M.D. Anderson Cancer Center, Kaiser Permanente, Early Detection Research Network
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov