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

NCT02441140 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2020-05-04

No results posted yet for this study

Summary

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

Conditions

  • Stage III Ovarian Cancer
  • Stage IV Ovarian Cancer

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Neil Horowitz, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2019-07-31
Completion
2019-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02441140 on ClinicalTrials.gov