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Clinical Trials/NCT02441140
NCT02441140TerminatedNot Applicable

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

Dana-Farber Cancer Institute2 sites in 1 country5 target enrollmentStarted: May 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
5
Locations
2
Primary Endpoint
Number of completed peritoneal fluid collection by culdocentesis after chromopertubation as an assessment of feasibility of peritoneal fluid collection in women with ovarian cancer.

Study Overview

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 Fluid is withdrawn from this space and sent for analysis.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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

  • •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

Arms & Interventions

Culdocentesis

Experimental
  • 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

Intervention: Tissue collection (Procedure)

Culdocentesis

Experimental
  • 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

Intervention: Culdocentesis (Procedure)

Culdocentesis

Experimental
  • 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

Intervention: Vaginal Swab (Procedure)

Culdocentesis

Experimental
  • 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

Intervention: Chromopertubation (Procedure)

Culdocentesis

Experimental
  • 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

Intervention: Blood collection (Procedure)

Outcomes

Primary Outcomes

Number of completed peritoneal fluid collection by culdocentesis after chromopertubation as an assessment of feasibility of peritoneal fluid collection in women with ovarian cancer.

Time Frame: At the time of surgery

Secondary Outcomes

  • Measure the concentration of cell free DNA in various biologic fluids and compare it to primary tumor DNA.(At the time of surgery)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Neil S. Horowitz, MD

Principal Investigator

Dana-Farber Cancer Institute

Study Sites (2)

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