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

NCT ID: NCT02441140

Last Updated: 2020-05-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2019-07-31

Brief Summary

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

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 Fluid is withdrawn from this space and sent for analysis.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

Conditions

Stage III Ovarian Cancer; Stage IV Ovarian Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Culdocentesis

Intervention Type: PROCEDURE

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

Vaginal Swab

Intervention Type: PROCEDURE

. 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.

Chromopertubation

Intervention Type: PROCEDURE

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.

Blood collection

Intervention Type: PROCEDURE

Intravenous blood collection will be drawn from an IV

Tissue collection

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Blood collection

Intravenous blood collection will be drawn from an IV

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Celula, Inc.

INDUSTRY

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Neil S. Horowitz, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Neil Horowitz, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

15-029

Identifier Type: -

Identifier Source: org_study_id