Clinical trial NCT02441140: Detection of Tumor Associated Cell-free DNA in Peritoneal Fluid Obtained by Culdocentesis
Official title: Detection of Tumor Associated Cell-free DNA in Peritoneal Fluid Obtained by Culdocentesis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stage III Ovarian Cancer
Stage IV Ovarian Cancer
Keywords: Stage III Ovarian Cancer
Stage IV Ovarian Cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Celula, Inc.
First posted: 2015-05-12
Enrollment: 5
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

Detailed 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 Fluid is withdrawn from this space and sent for analysis.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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of completed peritoneal fluid collection by culdocentesis after chromopertubation as an assessment of feasibility of peritoneal fluid collection in women with ovarian cancer.
timeFrame: At the time of surgery
Secondary outcomes:
measure: Measure the concentration of cell free DNA in various biologic fluids and compare it to primary tumor DNA.
timeFrame: At the time of surgery
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Neil Horowitz, MD
role: PRINCIPAL_INVESTIGATOR
References: