Ovarian Cancer Clinical Trial
— nCYTOfficial title:
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
NCT number | NCT03593681 |
Other study ID # | CLIN 0507 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 27, 2018 |
Est. completion date | February 14, 2020 |
Verified date | December 2020 |
Source | Boston Scientific Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 150 |
Est. completion date | February 14, 2020 |
Est. primary completion date | February 14, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Subject is medically cleared for surgery 2. Subject is scheduled to undergo salpingo-oophorectomy or salpingectomy for a pelvic mass suspicious for malignancy 3. Subject must be 18 years of age 4. Subject must be able to provide informed consent Exclusion Criteria: 1. Contraindication to hysteroscopy 2. Acute pelvic inflammatory disease 3. Active or recent lower pelvic infection 4. Pregnancy 5. Delivery or termination of a pregnancy in the past 6 weeks 6. Known tubal obstruction 7. Tubal ligation 8. Invasive carcinoma of the cervix or endometrium 9. Intolerance of anesthesia |
Country | Name | City | State |
---|---|---|---|
United States | University of Virginia | Charlottesville | Virginia |
United States | Baylor Scott & White Research Institute | Fort Worth | Texas |
United States | Mayo Clinic | Jacksonville | Florida |
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
United States | New York Presbyterian Hospital | New York | New York |
United States | Pennsylvania Hospital | Philadelphia | Pennsylvania |
United States | Mayo Clinic | Rochester | Minnesota |
United States | Scripps Clinic Medical Group | San Diego | California |
United States | Kaiser Permanente San Francisco Medical Center | San Francisco | California |
United States | Swedish Health Services | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Boston Scientific Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | PPV, NPV and Diagnostic Accuracy for Fallopian Tube Involvement | 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 | |
Secondary | Sensitivity, Specificity, PPV, NPV and Diagnostic Accuracy of the Fallopian Tube | 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 | |
Secondary | Sensitivity, Specificity, PPV, NPV and Diagnostic Accuracy of the Ovaries | 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 | |
Secondary | Sensitivity, Specificity, PPV, NPV and Diagnostic Accuracy for Subject Level Analysis | 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 |
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