Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

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

Infections

Symptoms and General Pathology

Communicable Diseases

Papillomavirus Infections

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Disease Attributes

Patients will perform vaginal cell collection beginning with the flocked swab, followed by the coton swab.

Patients will perform vaginal cell collection beginning with the coton swab, followed by the flocked swab.

Vaginal cell collection will be performed with the two types of indicated swab.

Vaginal swab

The purpose of this study is to compare the performance of cotton and flocked swabs for vaginal self-sampling.

Vaginal self-sampling for Human Papillomavirus (HPV) testing has been proposed as an efficient method cover hard-to reach populations in developing countries. While the recent cheap cotton swabs have traditionally been used for deoxyribonucleic acid (DNA) detection, recent studies have questioned their efficacy by reporting the superiority of the more expensive flocked swabs.

The objective of this study is to compare the performance of cotton vs flocked swabs for cellular retrieval and HPV DNA quantification after vaginal self-sampling.

A total of 120 women will be recruited. Inclusion criteria will be as follows: 21 years of age or older, attending the colposcopy clinic, understanding the study procedures and able to comply with the study protocol. Pregnant women, those having previously had a total hysterectomy, and women with ongoing menstruation will be excluded. Each woman will collect two different vaginal self samples: one with the cotton swab and one with the flocked swab. Subsequently, a flow cytometric analysis, as well as a real time PCR analysis and a cytologic evaluation for specimen adequacy will be run on each sample. Agreement between the two methods will be calculated using the kappa statistic (κ).

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
A Comparison of Cotton and Flocked Swabs for Vaginal Self Collection	NCT02785289	Human Papilloma...	Vaginal swab	21 Years - 65 Years	University Hospital, Geneva
A Comparison of Cotton and Flocked Swabs for Vaginal Self Collection	NCT02785289	Human Papilloma...	Vaginal swab	21 Years - 65 Years	University Hospital, Geneva
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
A Comparison of Cotton and Flocked Swabs for Vaginal Self Collection	NCT02785289	Human Papilloma...	Vaginal swab	21 Years - 65 Years	University Hospital, Geneva

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