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Hysteroscopic cell sampling of the fallopian tube

Ted L Anderson, MD,PhD,FACOG

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.

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

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

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.

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, 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, 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, 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.

Boston Scientific Corporation

Subjects who signed the informed consent and had hysteroscope placement attempted

Treated Subjects

Subjects from whom a signed informed consent form was obtained.

Cytuity Cytological Evaluation

Age at Baseline

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Height

Weight

Clinical Trial Project Manager

The number of true positive Cytuity cell samples divided by the number of true positives and the number of false negatives.

Sensitivity - Proportion of Cytuity Cell Samples That Correctly Identify the Presence of Disease

The number of true negative Cytuity cell samples divided by the number of true negatives and the number of false positives.

Specificity - Proportion of Cytuity Cell Samples That Correctly Identify the Absence of Disease

The number of Cytuity cell samples, not participants, was used for these endpoint analyses.

Sensitivity and Specificity of Cytological Samples for Fallopian Tube Involvement

The proportion of positive Cytuity cell samples that came from a fallopian tube found to have histology positive for malignancy and/or a corresponding ovary found to have histology positive for malignancy

PPV - Proportion of True Positive Results for Fallopian Tube Involvement

The proportion of negative Cytuity cell samples that came from a fallopian tube found to have histology negative for malignancy and a corresponding ovary found to have histology negative for malignancy

NPV - Proportion of True Negative Results for Fallopian Tube Involvement

The proportion of Cytuity cell sample results that conformed to the correct diagnosis as determined by the surgical histology results

Diagnostic Accuracy - Proportion of Accurate Diagnoses

PPV, NPV and Diagnostic Accuracy for Fallopian Tube Involvement

The number of true positive Cytuity cell samples divided by the number of true positive and the number of false negatives

The number of true negative Cytuity cell samples divided by the number of true negatives and the number of false positives

The proportion of positive Cytuity cell samples that came from a fallopian tube also found to have histology positive for malignancy

PPV - Proportion of True Positive Results for Fallopian Tube Pathology

The proportion of negative Cytuity cell samples that came from a fallopian tube also found to have histology negative for malignancy

NPV - Proportion of True Negative Results for Fallopian Tube Pathology

Sensitivity, Specificity, PPV, NPV and Diagnostic Accuracy of the Fallopian Tube

Number of true positive Cytuity cell samples divided by the number of true positives and the number of false negatives

The proportion of positive Cytuity cell samples that came from a fallopian tube adjacent to a corresponding ovary found to have histology positive for malignancy

PPV - Proportion of True Positive Results for Ovary Pathology for Epithelial Malignancy

The proportion of negative Cytuity cell samples that came from a fallopian tube adjacent to a corresponding ovary found to have histology truly negative for malignancy

NPV - Proportion of True Negatives for Ovary Pathology for Epithelial Malignancy

Sensitivity, Specificity, PPV, NPV and Diagnostic Accuracy of the Ovaries

Number of subjects with true positive Cytuity cell samples divided by the number of subjects with true positives and the number of subjects with false negatives

Sensitivity - Subjects in Which the Cytuity Correctly Identified the Presence of Disease

The number of subjects with true negative Cytuity cell samples divided by the number of subjects with true negatives and the number of subjects with false positives

Specificity - Subjects in Which the Cytuity Correctly Identified the Absence of Disease

The number of subjects with a positive Cytuity cell sample and a fallopian tube and/or corresponding ovary with histology positive for malignancy

PPV - True Positive Results for Fallopian Tube Involvement on Subject Level

The number of subjects with a negative Cytuity cell sample and a fallopian tube and corresponding ovary with histology negative for malignancy

NPV - True Negative Results for Fallopian Tube Involvement on Subject Level

The number of subjects with a Cytuity cell sample result that conformed to the correct diagnosis on a subject level as determined by the surgical histology results

Diagnostic Accuracy - Subjects With Accurate Diagnoses

Sensitivity, Specificity, PPV, NPV and Diagnostic Accuracy for Subject Level Analysis

Those subjects enrolled in the study, with hysteroscope placed, ostia visualized, and adequate Cytuity cell sample collected.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Compare Fallopian Tube Cells Collected by Cytuity With Removed Ovarian/Tubal Tissue to Determine Presence of Malignancy	NCT03593681	Fallopian Tube ... Ovarian Cancer Ovarian Neoplas... Ovary Cancer Fallopian Tube ... Fallopian Tube ... High Grade Sero... Peritoneal Carc... Peritoneal Neop... Adnexal Mass Ovarian Disease...	Hysteroscopic c...	18 Years -	Boston Scientific Corporation
Compare Fallopian Tube Cells Collected by Cytuity With Removed Ovarian/Tubal Tissue to Determine Presence of Malignancy	NCT03593681	Fallopian Tube ... Ovarian Cancer Ovarian Neoplas... Ovary Cancer Fallopian Tube ... Fallopian Tube ... High Grade Sero... Peritoneal Carc... Peritoneal Neop... Adnexal Mass Ovarian Disease...	Hysteroscopic c...	18 Years -	Boston Scientific Corporation

Spots Global Cancer Trial Database for hysteroscopic biopsy