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Carcinoma

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Genital Diseases, Female

Genital Diseases

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Female Urogenital Diseases and Pregnancy Complications

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Ovarian Cancer

Ovarian Epithelial Cancer

* Patients with known or highly likely ovarian cancer (i.e. highly elevated CA-125, ascites, pelvic mass) scheduled for cytoreductive surgery will be identified during preoperative consultation and offered participation in the study.
* During Surgery:

  * Blood Collection
  * Vaginal Swab
  * Chromopertubation
  * Culdocentesis
  * Tissue Collection

A sterile speculum will be placed in the vagina and the cervix identified. The cervix will be elevated using a tenaculum and a spinal needle inserted through the posterior vaginal fornix. Fluid from the posterior cul de sac will be collected

Culdocentesis

. A sterile speculum will be placed in the vagina and a Pap smear spatula will be used to swab the posterior fornix of the vagina. This swab will then be rinsed in a tube of saline.

Vaginal Swab

Chromopertubation is a common gynecologic technique used to test the patency of fallopian tubes during infertility evaluations. Fluid is flushed through the cervix and uterus and out the fallopian tubes.

Chromopertubation

Intravenous blood collection will be drawn from an IV

Blood collection

As part of the standard surgical procedure for presumed ovarian cancer, the primary tumor will be resected and a sample obtained for evaluation

Tissue collection

Neil Horowitz, MD

This research study is studying a possible test which may help doctors diagnose women with ovarian cancer.

This research study is a Feasibility Study, to try to evaluate whether or not culdocentesis can detect tumor associated cell free DNA. Although this is the first time investigators are using this type of procedure to detect cell free DNA, culdocentesis is not a new procedure. It used to be done routinely in the past to examine pelvic fluid. The investigator's goal is to develop a test to detect ovarian cancer in women before they develop any signs or symptoms of the disease. Currently, there is no screening test for ovarian cancer.

This study uses a technique called "culdocentesis" to detect DNA released by ovarian cancer cells into pelvic fluid. During culdocentesis, a small needle is inserted through the vagina into an empty space between the uterus and the rectum called the "cul-de-sac." Fluid is withdrawn from this space and sent for analysis. Culdocentesis is a technique that has been used for many years to examine pelvic fluid and determine its composition, but it has not previously been studied as a technique for examining cell-free DNA to detect ovarian cancer. The investigators suspect that this may be a useful way to detect cell-free DNA from ovarian cancer cells because the ovaries are very close to the cul-de-sac space.

In this study, the investigators will compare our ability to detect cell-free DNA in fluid from the cul-de-sac with our ability to detect cell-free DNA from a vaginal swab (similar to a Pap smear), a blood test, and in the tissue specimens collected at the time of surgery. The investigators are hoping to learn from this study whether developing a cell-free DNA test to screen for ovarian cancer involving culdocentesis would be an effective strategy.

Detection of Tumor Associated Cell-free DNA in Peritoneal Fluid Obtained by Culdocentesis

Celula, Inc.

Dana-Farber Cancer Institute

Principal Investigator

Women who present to the Gynecologic Oncology clinic with a pelvic mass who are scheduled to undergo surgical excision.

Laurent Brard, MD, PhD

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Detection of Tumor Associated Cell-free DNA in Peritoneal Fluid Obtained by Culdocentesis	NCT02441140	Stage III Ovari... Stage IV Ovaria...	Culdocentesis Vaginal Swab Chromopertubati... Blood collectio... Tissue collecti...	18 Years -	Dana-Farber Cancer Institute
Diagnostic Utility of Culdocentesis in Patients With a Suspicious Adnexal Mass	NCT02109367	Ovarian Cancer		30 Years -	Southern Illinois University
Detection of Tumor Associated Cell-free DNA in Peritoneal Fluid Obtained by Culdocentesis	NCT02441140	Stage III Ovari... Stage IV Ovaria...	Culdocentesis Vaginal Swab Chromopertubati... Blood collectio... Tissue collecti...	18 Years -	Dana-Farber Cancer Institute

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