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

Completed

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

• Registration Number: NCT03593681
• Lead Sponsor: Boston Scientific Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-10
• Study First Submitted QC: 2018-07-10
• Study First Posted: 2018-07-20
• Study Start: 2018-08-27
• Primary Completion: 2020-02-14
• Study Completion: 2020-02-14
• Results First Submitted: 2020-10-27
• Status Verified: 2020-12
• Results First Submitted QC: 2020-12-30
• Last Update Submitted: 2020-12-30
• Results First Posted: 2021-01-20
• Last Update Posted: 2021-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity and Specificity of Cytological Samples for Fallopian Tube Involvement	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.

Secondary Outcome Measures

Name	Time	Method
PPV, NPV and Diagnostic Accuracy for Fallopian Tube Involvement	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.
Sensitivity, Specificity, PPV, NPV and Diagnostic Accuracy of the Fallopian Tube	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.
Sensitivity, Specificity, PPV, NPV and Diagnostic Accuracy of the Ovaries	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.
Sensitivity, Specificity, PPV, NPV and Diagnostic Accuracy for Subject Level Analysis	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.

Trial Locations

Locations (9)

Scripps Clinic Medical Group; 🇺🇸 San Diego, California, United States

Kaiser Permanente San Francisco Medical Center; 🇺🇸 San Francisco, California, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

New York Presbyterian Hospital; 🇺🇸 New York, New York, United States

Pennsylvania Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

Baylor Scott & White Research Institute; 🇺🇸 Fort Worth, Texas, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

Swedish Health Services; 🇺🇸 Seattle, Washington, United States