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Purpose

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

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Culdocentesis 		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
  • Procedure: Culdocentesis
    A sterile speculum will be placed in the vagina and the cervix identified. The cervix will be elevated using a tenaculum and a spinal needle inserted through the posterior vaginal fornix. Fluid from the posterior cul de sac will be collected
  • Procedure: Vaginal Swab
    . A sterile speculum will be placed in the vagina and a Pap smear spatula will be used to swab the posterior fornix of the vagina. This swab will then be rinsed in a tube of saline.
  • Procedure: Chromopertubation
    Chromopertubation is a common gynecologic technique used to test the patency of fallopian tubes during infertility evaluations. Fluid is flushed through the cervix and uterus and out the fallopian tubes.
  • Procedure: Blood collection
    Intravenous blood collection will be drawn from an IV
  • Procedure: Tissue collection
    As part of the standard surgical procedure for presumed ovarian cancer, the primary tumor will be resected and a sample obtained for evaluation

More Details

Status
Terminated
Sponsor
Dana-Farber Cancer Institute

Study Contact

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.