Compare Fallopian Tube Cells Collected by Cytuity With Removed Ovarian/Tubal Tissue to Determine Presence of Malignancy (nCYT)

December 30, 2020 updated by: Boston Scientific Corporation

The nCYT Study: A Powered Study to Evaluate the Sensitivity and Specificity of Cytological Evaluation of Fallopian Tube Samples Collected by the Cytuity in Determining the Presence of Malignancy

Prospective, multi-center, non-randomized study to assess the ability of the Cytuity device to collect cell samples from the fallopian tube that can be evaluated for the presence or absence of malignancy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Device: Hysteroscopic cell sampling of the fallopian tube

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - San Diego, California, United States, 92103
    - Scripps Clinic Medical Group
  - San Francisco, California, United States, 94115
    - Kaiser Permanente San Francisco Medical Center
- Florida
  - Jacksonville, Florida, United States, 32224
    - Mayo Clinic
- Minnesota
  - Rochester, Minnesota, United States, 55905
    - Mayo Clinic
- New York
  - New York, New York, United States, 10032
    - New York Presbyterian Hospital
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19107
    - Pennsylvania Hospital
- Tennessee
  - Nashville, Tennessee, United States, 37232
    - Vanderbilt University Medical Center
- Texas
  - Fort Worth, Texas, United States, 76104
    - Baylor Scott & White Research Institute
- Virginia
  - Charlottesville, Virginia, United States, 22908
    - University of Virginia
- Washington
  - Seattle, Washington, United States, 98104
    - Swedish Health Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Subjects who are scheduled to undergo a salpingo-oophorectomy or salpingectomy because of a pelvic mass suspicious for malignancy.

Description

Inclusion Criteria:

Subject is medically cleared for surgery
Subject is scheduled to undergo salpingo-oophorectomy or salpingectomy for a pelvic mass suspicious for malignancy
Subject must be 18 years of age
Subject must be able to provide informed consent

Exclusion Criteria:

Contraindication to hysteroscopy
Acute pelvic inflammatory disease
Active or recent lower pelvic infection
Pregnancy
Delivery or termination of a pregnancy in the past 6 weeks
Known tubal obstruction
Tubal ligation
Invasive carcinoma of the cervix or endometrium
Intolerance of anesthesia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Case-Only
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and Specificity of Cytological Samples for Fallopian Tube Involvement Time Frame: At the time of the scheduled salpingectomy or salpingo-oophorectomy	Evaluate the sensitivity and specificity of the cytological samples collected from the fallopian tube in determining the presence or absence of malignancy for fallopian tube involvement as compared to the surgical histology results. Fallopian tube involvement was defined as: 1. Malignant cells that originated in the fallopian tube, detected by the surgical histology results from the fallopian tube. 2. Malignant cells that have migrated to the fallopian tube, detected by surgical histology results of the ovaries or fallopian tube.	At the time of the scheduled salpingectomy or salpingo-oophorectomy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PPV, NPV and Diagnostic Accuracy for Fallopian Tube Involvement Time Frame: At the time of the scheduled salpingectomy or salpingo-oophorectomy	Positive Predictive Value, Negative Predictive Value and Diagnostic Accuracy will be calculated for Cytuity as compared to surgical histology of the ovaries and fallopian tube for fallopian tube involvement. Fallopian tube involvement was defined as: 1. Malignant cells that originated in the fallopian tube, detected by the surgical histology results from the fallopian tube. 2. Malignant cells that have migrated to the fallopian tube, detected by surgical histology results of the ovaries or fallopian tube.	At the time of the scheduled salpingectomy or salpingo-oophorectomy
Sensitivity, Specificity, PPV, NPV and Diagnostic Accuracy of the Fallopian Tube Time Frame: At the time of the scheduled salpingectomy or salpingo-oophorectomy	Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value and Diagnostic Accuracy will be calculated for Cytuity as compared to surgical histology of the fallopian tube.	At the time of the scheduled salpingectomy or salpingo-oophorectomy
Sensitivity, Specificity, PPV, NPV and Diagnostic Accuracy of the Ovaries Time Frame: At the time of the scheduled salpingectomy or salpingo-oophorectomy	Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value and Diagnostic Accuracy will be calculated for Cytuity as compared to surgical histology of the ovaries for epithelial malignancies.	At the time of the scheduled salpingectomy or salpingo-oophorectomy
Sensitivity, Specificity, PPV, NPV and Diagnostic Accuracy for Subject Level Analysis Time Frame: At the time of the scheduled salpingectomy or salpingo-oophorectomy	Sensitivity, Specificity, Positive Predictive Value, Negative Predictive Value and Diagnostic Accuracy will be calculated for Cytuity as compared to surgical histology for fallopian tube involvement at the subject level. Fallopian tube involvement was defined as: 1. Malignant cells that originated in the fallopian tube, detected by the surgical histology results from the fallopian tube. 2. Malignant cells that have migrated to the fallopian tube, detected by surgical histology results of the ovaries or fallopian tube.	At the time of the scheduled salpingectomy or salpingo-oophorectomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

Principal Investigator: Ted L Anderson, MD,PhD,FACOG, Vanderbilt University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 27, 2018

Primary Completion (Actual)

February 14, 2020

Study Completion (Actual)

February 14, 2020

Study Registration Dates

First Submitted

July 10, 2018

First Submitted That Met QC Criteria