Compare Fallopian Tube Cells Collected by Cytuity With Removed Ovarian/Tubal Tissue to Determine Presence of Malignancy
nCYT
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
1 other identifier
observational
150
1 country
10
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2018
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 10, 2018
CompletedFirst Posted
Study publicly available on registry
July 20, 2018
CompletedStudy Start
First participant enrolled
August 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 14, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 14, 2020
CompletedResults Posted
Study results publicly available
January 20, 2021
CompletedJanuary 20, 2021
December 1, 2020
1.5 years
July 10, 2018
October 27, 2020
December 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sensitivity and Specificity of Cytological Samples for Fallopian Tube Involvement
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 Outcomes (4)
PPV, NPV and Diagnostic Accuracy for Fallopian Tube Involvement
At the time of the scheduled salpingectomy or salpingo-oophorectomy
Sensitivity, Specificity, PPV, NPV and Diagnostic Accuracy of the Fallopian Tube
At the time of the scheduled salpingectomy or salpingo-oophorectomy
Sensitivity, Specificity, PPV, NPV and Diagnostic Accuracy of the Ovaries
At the time of the scheduled salpingectomy or salpingo-oophorectomy
Sensitivity, Specificity, PPV, NPV and Diagnostic Accuracy for Subject Level Analysis
At the time of the scheduled salpingectomy or salpingo-oophorectomy
Interventions
Hysteroscopic fallopian tube biopsy
Eligibility Criteria
Subjects who are scheduled to undergo a salpingo-oophorectomy or salpingectomy because of a pelvic mass suspicious for malignancy.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Scripps Clinic Medical Group
San Diego, California, 92103, United States
Kaiser Permanente San Francisco Medical Center
San Francisco, California, 94115, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
New York Presbyterian Hospital
New York, New York, 10032, United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Baylor Scott & White Research Institute
Fort Worth, Texas, 76104, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Swedish Health Services
Seattle, Washington, 98104, United States
Biospecimen
Tissue and Cells
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial Project Manager
- Organization
- Boston Scientific
Study Officials
- PRINCIPAL INVESTIGATOR
Ted L Anderson, MD,PhD,FACOG
Vanderbilt University Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 10, 2018
First Posted
July 20, 2018
Study Start
August 27, 2018
Primary Completion
February 14, 2020
Study Completion
February 14, 2020
Last Updated
January 20, 2021
Results First Posted
January 20, 2021
Record last verified: 2020-12