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 BRCA1 or BRCA2 mutation who are scheduled for a risk-reducing salpingo-oophorectomy.

The study will examine DNA 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 BRCA1 or BRCA2 mutation who are scheduled for risk-reducing salpingo-oophorectomy (RRSO) to remove ovaries and fallopian tubes.

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 bilateral 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 BRCA1 or BRCA2 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.
• Lynch syndrome