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Trial Title:
Diagnostic Utility of Culdocentesis in Patients With a Suspicious Adnexal Mass
NCT ID:
NCT02109367
Condition:
Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Conditions: Keywords:
ovarian cancer
ovarian mass
CA-125
HE4
culdocentesis
biomarker(s)
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Prospective
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.
Detailed description:
This is a single cohort, exploratory pilot study of 60 participants to assess if ovarian
cancer markers, cancer antigen-125 (CA-125) and human epididymis protein 4 (HE4), are
measurable from cul-de-sac washings collected via culdocentesis. Immediately prior to the
scheduled surgery, while the patient is under general anesthesia, a long, thin needle
will be inserted through the wall of the vagina (just below the uterus) to access the
cul-de-sac. A saline wash will then be performed and this fluid will be collected for
analysis of tumor markers. CA-125 and HE4 levels will be compared to serum levels for
correlation with a diagnosis of ovarian cancer. A urine sample will also be collected
from this same cohort to measure estrogen metabolites. Estrogen metabolism is associated
with cancer progression in estrogen sensitive tissues. Estrogen metabolites,
2-hydroxyestrone (2-OHE1) the "good" byproduct and 16α-hydroxyestrone (16α-OHE1) known as
the "bad" byproduct, have been implicated in the development of breast cancer. Study
investigators are proposing to expand the utility of this predictive ratio to ovarian
cancer by measuring the potential imbalance of these metabolites.
If results indicate an association between cancer diagnosis and levels of CA-125 and HE4
or the ratio of estrogen metabolites from the urine, this could allow for a new minimally
invasive, low-risk diagnostic modality for all suspected ovarian cancer cases. This would
be particularly invaluable for patients at higher risk for poor surgical outcomes. Data
from this pilot study will confirm the potential effect size needed to identify an
optimal cut-point useful for the prediction of EOC within this study population.
Criteria for eligibility:
Study pop:
Adult women with a suspicious adnexal mass that could possibly be ovarian cancer who are
scheduled for oophorectomy, bilateral salpingo-oophorectomy (BSO), hysterectomy via
laparotomy or laparoscopy, hysterectomy/BSO, staging and/or debulking.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion criteria:
- 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.
Exclusion criteria:
- 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.
Gender:
Female
Minimum age:
30 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Southern Illinois University School of Medicine
Address:
City:
Springfield
Zip:
62794-9640
Country:
United States
Start date:
February 2014
Completion date:
June 2024
Lead sponsor:
Agency:
Southern Illinois University
Agency class:
Other
Collaborator:
Agency:
National Institutes of Health (NIH)
Agency class:
NIH
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Southern Illinois University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02109367