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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02441140
Recruitment Status : Recruiting
First Posted : May 12, 2015
Last Update Posted : July 11, 2018
Celula, Inc.
Information provided by (Responsible Party):
Neil S. Horowitz, MD, Dana-Farber Cancer Institute

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

Condition or disease Intervention/treatment Phase
Stage III Ovarian Cancer Stage IV Ovarian Cancer Procedure: Culdocentesis Procedure: Vaginal Swab Procedure: Chromopertubation Procedure: Blood collection Procedure: Tissue collection Not Applicable

Detailed Description:

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 Fluid is withdrawn from this space and sent for analysis.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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Detection of Tumor Associated Cell-free DNA in Peritoneal Fluid Obtained by Culdocentesis
Study Start Date : May 2015
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Experimental: Culdocentesis
  • 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
Procedure: Culdocentesis
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

Procedure: Vaginal Swab
. 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.

Procedure: Chromopertubation
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.

Procedure: Blood collection
Intravenous blood collection will be drawn from an IV

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

Primary Outcome Measures :
  1. Number of completed peritoneal fluid collection by culdocentesis after chromopertubation as an assessment of feasibility of peritoneal fluid collection in women with ovarian cancer. [ Time Frame: At the time of surgery ]

Secondary Outcome Measures :
  1. Measure the concentration of cell free DNA in various biologic fluids and compare it to primary tumor DNA. [ Time Frame: At the time of surgery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Female
  • Age ≥ 18
  • Able to give informed consent
  • Scheduled for surgery at Brigham and Women's Hospital for known or highly suspected Stage III or IV ovarian cancer (i.e. elevated CA-125 with a pelvic mass, ascites, and carcinomatosis)
  • Post-menopausal or negative urine and/or blood pregnancy test
  • Measurable disease on preoperative imaging

Exclusion Criteria:

  • Male
  • Age < 18
  • Unable to give informed consent
  • Not planned for surgical intervention
  • Active malignancy other than ovarian cancer
  • Prior bilateral tubal ligation or hysterectomy (as this would prevent chromopertubation)
  • Known or suspected active pelvic infection
  • Pregnancy
  • No measurable disease or suspected Stage I or II ovarian cancer on preoperative imaging

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02441140

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Contact: Neil Horowitz, MD 617 732-8843

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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Neil Horowitz, MD    617-732-8843   
Principal Investigator: Neil Horowitz, MD         
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Neil Horowitz, MD    617-732-8843   
Principal Investigator: Neil Horowitz, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Celula, Inc.
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Principal Investigator: Neil Horowitz, MD Dana-Farber Cancer Institute

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Responsible Party: Neil S. Horowitz, MD, Principal Investigator, Dana-Farber Cancer Institute Identifier: NCT02441140     History of Changes
Other Study ID Numbers: 15-029
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: May 2018

Keywords provided by Neil S. Horowitz, MD, Dana-Farber Cancer Institute:
Stage III Ovarian Cancer
Stage IV Ovarian Cancer

Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type