Diagnostic Utility of Culdocentesis in Patients With a Suspicious Adnexal Mass
Completed
Conditions studied: Ovarian Cancer
In brief
This study involves women who are scheduled to have surgery for a pelvic or ovarian mass that is suspicious for epithelial ovarian cancer (EOC). The physician will perform an additional procedure on all consented subjects known as 'culdocentesis'. This will be done just prior to their scheduled surgery while the patient is under general anesthesia. Culdocentesis is a procedure typically used to check for abnormal fluid in the space just behind the vagina. This pocket of space is called the cul-de-sac. The purpose of this study is to determine if levels of tumor markers, CA-125 and HE4, are measurable from the cul-de-sac fluid. If these tumor markers are measurable from the cul-de-sac fluid and correlate with the patient's diagnosis, this procedure may be used in the future as an additional diagnostic tool for EOC. In addition, a single urine sample will be collected from each patient to measure the ratio of "good" to "bad" estrogen. Investigators hypothesize this ratio will also correlate with EOC diagnosis. Study results could lead to development of an alternative, minimally invasive and low risk diagnostic tool in patients with an ovarian mass suspicious for malignancy.
Key facts
- Study ID
- NCT02109367
- Run by
- Southern Illinois University
- People needed
- 52
- Starts
- 2014-02-01
- Expected to finish
- 2026-03-01
- Last updated by the study team
- 2026-04-22
Who can join
Age: 30 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Patients age ≥ 30.
- Adnexal mass or suspected ovarian carcinoma.
- Patient has been scheduled for oophorectomy, bilateral salpingo- oophorectomy (BSO), hysterectomy, hysterectomy/BSO, staging or debulking.
- Willingness to sign an Informed Consent document.
You may not qualify if…
- Patients previously diagnosed with a malignancy within the pelvis or abdomen.
- Patients in which culdocentesis is technically unfeasible due to previous surgery (extensive pelvic floor repair/colpocleisis) or other anatomic abnormalities that make the cul-de-sac inaccessible.
Where it is running
- Southern Illinois University School of Medicine — Springfield, Illinois, United States
Full record on ClinicalTrials.gov
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