- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03593681
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
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
-
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California
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San Diego, California, United States, 92103
- Scripps Clinic Medical Group
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San Francisco, California, United States, 94115
- Kaiser Permanente San Francisco Medical Center
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Florida
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Jacksonville, Florida, United States, 32224
- Mayo Clinic
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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New York
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New York, New York, United States, 10032
- New York Presbyterian Hospital
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Pennsylvania Hospital
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt University Medical Center
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Texas
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Fort Worth, Texas, United States, 76104
- Baylor Scott & White Research Institute
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Virginia
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Charlottesville, Virginia, United States, 22908
- University of Virginia
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Washington
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Seattle, Washington, United States, 98104
- Swedish Health Services
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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
No
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.
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At the time of the scheduled salpingectomy or salpingo-oophorectomy
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Sensitivity, Specificity, PPV, NPV and Diagnostic Accuracy of the Ovaries
Time Frame: At the time of the scheduled salpingectomy or salpingo-oophorectomy
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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.
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At the time of the scheduled salpingectomy or salpingo-oophorectomy
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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
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
July 10, 2018
First Posted (Actual)
July 20, 2018
Study Record Updates
Last Update Posted (Actual)
January 20, 2021
Last Update Submitted That Met QC Criteria
December 30, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Urogenital Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Peritoneal Diseases
- Genital Neoplasms, Female
- Endocrine System Diseases
- Adnexal Diseases
- Gonadal Disorders
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Fallopian Tube Diseases
- Abdominal Neoplasms
- Cystadenocarcinoma
- Neoplasms, Cystic, Mucinous, and Serous
- Neoplasms
- Carcinoma
- Ovarian Neoplasms
- Fallopian Tube Neoplasms
- Peritoneal Neoplasms
- Cystadenocarcinoma, Serous
- Ovarian Diseases
Other Study ID Numbers
- CLIN 0507
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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