Ovarian Cancer Detection by Uterine Lavage DNA and Serum Proteins: a Phase 2 Biomarker Study
Massachusetts General Hospital
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.
Description
The study aims to elucidate the relative contributions to detection of ovarian cancer from tumor DNA in uterine lavage (UL) and protein biomarkers from blood using newly available detection and sample collection technologies. In this document, the term "ovarian cancer" includes fallopian tube cancer. In the first cohort, the study will enroll 200 participants. Enrolling participants prior to surgical diagnosis (e.g. laparoscopy or paracentesis) ensures the study will be "Prospective Collection of Samples, Blinded Evaluation" (PRoBE) compliant. The expectation is that \~50 of these participants…
Eligibility
- Age range
- 30+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * 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 Exclusion Criteria: * Current tissue or cytology diagnostic procedure positive for ovary cancer or any cancer * Inability to provide informed consent * Age less than 30 years * Inability to obtain the minimum amoun…
Interventions
- Diagnostic TestUterine 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 TestBlood sample
Participants undergo two blood draws (one required, one optional) up to 31 days before surgery
- Diagnostic TestPap smear
Participants undergo a standard Papanicolaou smear to collect cells and fluid from the cervix.
Locations (6)
- University of Arkansas for Medical SciencesLittle Rock, Arkansas
- Kaiser Permanente - San FranciscoSan Francisco, California
- Anne Arundel Health SystemAnnapolis, Maryland
- Johns Hopkins University School of MedicineBaltimore, Maryland
- Massachusetts General HospitalBoston, Massachusetts
- The Swedish HospitalSeattle, Washington