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NCT02109367 · ClinicalTrials.gov registry record
Diagnostic Utility of Culdocentesis in Patients With a Suspicious Adnexal Mass
A clinical trial of Ovarian Cancer, sponsored by Southern Illinois University.
- Active
- Registry status
- 60
- Enrollment target
- 1
- Study location
NCT02109367: Active study of Ovarian Cancer, sponsored by Southern Illinois University.
NCT02109367 is a study of Ovarian Cancer that is active but no longer recruiting, run by Southern Illinois University. The registered enrollment target is 60 participants, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02109367, a study of Ovarian Cancer, is active but no longer recruiting, sponsored by Southern Illinois University.
- ACTIVE NOT RECRUITING
- Registry status
- 60 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
ELISA
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 |
What the registry record for NCT02109367 still lists
NCT02109367 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Ovarian Cancer appearing as the primary indexed condition, and to 0 interventions.
NCT02109367 reports a single indexed study location in Illinois.
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.
Who is sponsoring clinical trial NCT02109367?
This trial is sponsored by Southern Illinois University, which has 21 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT02109367's enrollment target sits among peer trials
60 193rd of 322 higher than 123 of 322 other Ovarian Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ovarian Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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