Clinicaltrials.gov identifier:
NCT04794322
Prevention
Prevention study for women with a BRCA1 or BRCA2 mutation who are scheduled for risk-reducing salpingo-oophorectomy
Study Contact Information:
Natalie Waldron by phone: 978-394-2030 or by email
Jackie Dahlgren by email
Developing a Test for the Detection of Ovarian Cancer
About the Study
The purpose of this study is to develop a test for early detection of ovarian cancer. Two patient populations are included in this study: women scheduled for surgery or testing for suspected but undiagnosed ovarian/fallopian tube cancer, and women with a or mutation who are scheduled for a risk-reducing salpingo-oophorectomy.
The study will examine from a washing of the uterus (womb) and proteins found in the blood to see how much the study participants with ovarian cancer can be separated from the participants with a benign ovarian 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, and thus improve rates of early detection of ovarian cancer.
What the Study Entails
Study participants will be recruited from two separate groups:
- Study Group 1 will include women who are suspected to have ovarian cancer due to a pelvic mass but without a confirmed tissue or cell diagnosis.
- Study Group 2 will include women with an inherited or mutation who are scheduled for risk-reducing salpingo-oophorectomy () to remove ovaries and .
Both Study Group 1 and Study Group 2 will have the following diagnostic tests performed.
- Blood sample - Participants undergo two blood draws (one required, one optional) up to 31 days before surgery
- Pap smear - Participants undergo a standard Pap smear to collect cells and fluid from the cervix.
- Uterine wash – This is performed during surgery, with sterile saline, which is then collected and stored for later analysis.
Participants will not receive the results of their test.
Study Sites:
Arkansas
- Little Rock
University of Arkansas for Medical Sciences
Contact: Beth Scanlan by phone: 501-686-8274 or by email
Principal Investigator: Heather Williams, MD
California
- San Francisco
Kaiser Permanente
Contact: Isabel Perez by phone: 415-833-3480 or by email
Principal Investigator: Christine Garcia, MD
Maryland
- Annapolis
Anne Arundel Health System
Contact: Jaci Miller by phone: 443-481-5738 or by email
Principal Investigator: Monica Jones, MD - Baltimore
Johns Hopkins University School of Medicine
Contact: Rebecca Stone, MD by email
Principal Investigator: Rebecca Stone, MD
Massachusetts
- Boston
Massachusetts General Hospital
Contact: Tina Colella by phone: 617-643-5150 or by email
Principal Investigator: Amy Bregar, MD
Washington
- Seattle
The Swedish Hospital
Contact: Lindsay Bergan, 206-667-6111 or by email
Principal Investigator: Charles Drescher, MD
Women, age 30 years or older, are eligible if they:
- Have an intact uterus (no history of uterine ablation, tubal ligation or salpingectomy)
- Study Group 1 Participants: Women scheduled for surgery or diagnostic laparoscopy for suspected but undiagnosed ovarian/fallopian tube cancer
- Study Group 2 Participants: Women with known or mutation scheduled for risk-reducing salpingo-oophorectomy
Women cannot participate if they have any of the following:
- Current diagnosis of ovarian cancer or any cancer
- Prior history of 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, or CIN3 (a precancerous condition in which abnormal cell growth occurs in and around a woman’s cervix)
- History of treated CIN3 with an abnormal pap smear in the past year.