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Diagnostic Utility of Culdocentesis in Patients with a Suspicious Adnexal Mass

IRB Number

12-656

ClinicalTrials.gov Identifier

N/A

Trial Status

Open for Enrollment
Phase Observational/Behavioral

Why is this study being done?

The goal of this study is to determine if certain tumor markers, CA-125 and HE4, are present in the fluid within your abdominal cavity (peritoneal fluid). We hope that when these tumor markers are measured together along with the cells present in this fluid, they may be used in the future as an early diagnostic tool for women with an adnexal mass (ovarian cyst) suspicious for a malignancy.

Who is eligible to participate?

Women age 30 or older diagnosed with an adnexal mass or suspected ovarian cancer; patients scheduled for oophorectomy, bilateral salpingo-oopherectomy (BSO), hysterectomy, hysterectomy/BSO, staging or debulking.

What is involved?

Just prior to your surgery, when you are already under general anesthesia, we will perform a procedure called culdocentesis. This involves inserting a long, thin needle through the wall of the vagina (just below the uterus). A sample of any fluid (ascites) found in this space will be collected and an additional peritoneal washing will be performed at this time. A small amount (about 1 and 1/3 cups) of 0.9% NaCl (saline solution) will be infused into the cul-de-sac (small area just behind the vagina). Part of this fluid will be collected and placed in a vial that will be sent to pathology. The remaining fluid will be collected, frozen and sent to a reference laboratory for analysis of CA-125 and HE4 levels. The results from this fluid sample will be compared to levels of these same serum markers previously analyzed for standard of care. Once the culdocentesis procedure is completed, you will undergo your surgery as scheduled. A peritoneal wash is also performed during this procedure as standard of care.

How long is the study?

You will be actively participating in this study only for the duration of your already scheduled procedure. However, it is unknown when the samples that are collected will be analyzed.

Who can I contact for additional information?

Please contact Kathy Groesch at 217-545-6671 or email kgroesch@siumed.edu

Who is the Principal Investigator of this study?

Laurent Brard, MD

Where is the trial located?

Springfield, Illinois