Diagnostic Utility of Culdocentesis in Patients With a Suspicious Adnexal Mass
| Status: | Recruiting |
|---|---|
| Conditions: | Ovarian Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 30 - Any |
| Updated: | 4/27/2018 |
| Start Date: | February 2014 |
| End Date: | June 2022 |
| Contact: | Laurent Brard, MD, PhD |
| Email: | lbrard@siumed.edu |
| Phone: | 217-545-8882 |
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.
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.
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.
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.
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.
We found this trial at
1
site
801 N Rutledge St
Springfield, Illinois 62702
Springfield, Illinois 62702
(217) 545-8000
Phone: 217-545-8000
Southern Illinois University School of Medicine At SIU School of Medicine, research includes biologically oriented...
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