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Diagnostic Utility of Culdocentesis in Patients With a Suspicious Adnexal Mass
NCT02109367 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Study Locations (1)
Illinois
- Southern Illinois University School of Medicine — Springfield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2014-02 |
| Est. Completion | 2024-06 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02109367
The ClinicalTrials.gov registry entry for NCT02109367 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Southern Illinois University, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Ovarian Cancer appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02109367 reports 1 study location spanning 1 distinct geographic area — top geographies include Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02109367 about?
NCT02109367 is a clinical study titled "Diagnostic Utility of Culdocentesis in Patients With a Suspicious Adnexal Mass". 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 surg...
What is the current status of trial NCT02109367?
This trial is currently active not recruiting. The enrollment target is 60 participants. The study started on 2014-02. Estimated completion is 2024-06.
What conditions does trial NCT02109367 study?
This clinical trial studies the following conditions: Ovarian Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT02109367?
This trial is sponsored by Southern Illinois University, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02109367 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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