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

Ovarian Cancer Clinical Trial

— nCYT  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03593681
• Other study ID #: CLIN 0507
• Status: Completed
• Start date: August 27, 2018
• Est. completion date: February 14, 2020

Study information

• Verified date: December 2020
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Adnexal Mass
• Carcinoma
• Fallopian Tube Adenocarcinoma
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• High Grade Serous Carcinoma
• Neoplasms
• Ovarian Cancer
• Ovarian Diseases
• Ovarian Neoplasms
• Ovary Cancer
• Peritoneal Carcinoma
• Peritoneal Neoplasms

Intervention

Device:
• Hysteroscopic cell sampling of the fallopian tube
Hysteroscopic fallopian tube biopsy

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

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