Detection of Tumor Associated Cell-free DNA in Peritoneal Fluid Obtained by Culdocentesis

Dana-Farber Cancer Institute

Status: Terminated

Conditions: Stage III Ovarian Cancer; Stage IV Ovarian Cancer

Treatments: Procedure: Tissue collection; Procedure: Vaginal Swab; Procedure: Culdocentesis; Procedure: Blood collection; Procedure: Chromopertubation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02441140

15-029

Details and patient eligibility

About

This research study is studying a possible test which may help doctors diagnose women with ovarian cancer.

Full description

This research study is a Feasibility Study, to try to evaluate whether or not culdocentesis can detect tumor associated cell free DNA. Although this is the first time investigators are using this type of procedure to detect cell free DNA, culdocentesis is not a new procedure. It used to be done routinely in the past to examine pelvic fluid. The investigator's goal is to develop a test to detect ovarian cancer in women before they develop any signs or symptoms of the disease. Currently, there is no screening test for ovarian cancer.

This study uses a technique called "culdocentesis" to detect DNA released by ovarian cancer cells into pelvic fluid. During culdocentesis, a small needle is inserted through the vagina into an empty space between the uterus and the rectum called the "cul-de-sac." Fluid is withdrawn from this space and sent for analysis. Culdocentesis is a technique that has been used for many years to examine pelvic fluid and determine its composition, but it has not previously been studied as a technique for examining cell-free DNA to detect ovarian cancer. The investigators suspect that this may be a useful way to detect cell-free DNA from ovarian cancer cells because the ovaries are very close to the cul-de-sac space.

In this study, the investigators will compare our ability to detect cell-free DNA in fluid from the cul-de-sac with our ability to detect cell-free DNA from a vaginal swab (similar to a Pap smear), a blood test, and in the tissue specimens collected at the time of surgery. The investigators are hoping to learn from this study whether developing a cell-free DNA test to screen for ovarian cancer involving culdocentesis would be an effective strategy.

Enrollment: 5 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female
• Age ≥ 18
• Able to give informed consent
• Scheduled for surgery at Brigham and Women's Hospital for known or highly suspected Stage III or IV ovarian cancer (i.e. elevated CA-125 with a pelvic mass, ascites, and carcinomatosis)
• Post-menopausal or negative urine and/or blood pregnancy test
• Measurable disease on preoperative imaging

Exclusion criteria

• Male
• Age < 18
• Unable to give informed consent
• Not planned for surgical intervention
• Active malignancy other than ovarian cancer
• Prior bilateral tubal ligation or hysterectomy (as this would prevent chromopertubation)
• Known or suspected active pelvic infection
• Pregnancy
• No measurable disease or suspected Stage I or II ovarian cancer on preoperative imaging

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

5 participants in 1 patient group

Culdocentesis

Experimental group

Description:

* Patients with known or highly likely ovarian cancer (i.e. highly elevated CA-125, ascites, pelvic mass) scheduled for cytoreductive surgery will be identified during preoperative consultation and offered participation in the study. * During Surgery: * Blood Collection * Vaginal Swab * Chromopertubation * Culdocentesis * Tissue Collection

Treatment:

Procedure: Tissue collection

Procedure: Vaginal Swab

Procedure: Culdocentesis

Procedure: Blood collection

Procedure: Chromopertubation