Diagnostic Utility of Culdocentesis in Patients With a Suspicious Adnexal Mass

Study Overview
=================
Brief 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.

Official Title
-----------------
Diagnostic Utility of Culdocentesis in Patients With a Suspicious Adnexal Mass

Conditions
-----------------
Ovarian Cancer

Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pelvic mass<br>Women who present to the Gynecologic Oncology clinic with a pelvic mass who are scheduled to undergo surgical excision. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HE4 and CA-125 from cul-de-sac wash | ELISA | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-hydroxyestrone (2-OHE1) and 16α-hydroxyestrone (16α-OHE1) from urine | ELISA | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HE4, ovarian cancer, ovarian mass, CA-125, culdocentesis, biomarker(s)