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

Study Overview
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Brief Summary
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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.

Official Title
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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

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

Intervention / Treatment
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* Device: Hysteroscopic cell sampling of the fallopian tube


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Hysteroscopic cell sampling of the fallopian tube|Hysteroscopic fallopian tube biopsy|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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salpingo-oophorectomy, salpingectomy, ovarian cancer, fallopian tube cancer, high grade serous carcinoma, hysteroscopic biopsy, fallopian tube cell collection, peritoneal cancer