| 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. | The number of Cytuity cell samples, not participants, was used for these endpoint analyses. | Posted | | Number | 95% Confidence Interval | Proportion of Cytuity Cell Samples | | At the time of the scheduled salpingectomy or salpingo-oophorectomy | Cytuity Cell Samples | Cytuity Cell Samples | | ID | Title | Description |
|---|
| OG000 | Sensitivity - Proportion of Cytuity Cell Samples That Correctly Identify the Presence of Disease | The number of true positive Cytuity cell samples divided by the number of true positives and the number of false negatives. | | OG001 | Specificity - Proportion of Cytuity Cell Samples That Correctly Identify the Absence of Disease | The number of true negative Cytuity cell samples divided by the number of true negatives and the number of false positives. |
| | Units | Counts |
|---|
| Participants | | | Cytuity Cell Samples | |
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000.143(.029 to .479)
- OG001.959(.911 to .981)
|
|
| |
| 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. | The number of Cytuity cell samples, not participants, was used for these endpoint analyses. | Posted | | Number | 95% Confidence Interval | Proportion of Cytuity Cell Samples | | At the time of the scheduled salpingectomy or salpingo-oophorectomy | Cytuity Cell Samples | Cytuity Cell Samples | | ID | Title | Description |
|---|
| OG000 | PPV - Proportion of True Positive Results 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 | | OG001 | NPV - Proportion of True Negative 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 |
|
| 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. | The number of Cytuity cell samples, not participants, was used for these endpoint analyses. | Posted | | Number | 95% Confidence Interval | Proportion of Cytuity Cell Samples | | At the time of the scheduled salpingectomy or salpingo-oophorectomy | Cytuity Cell Samples | Cytuity Cell Samples | | ID | Title | Description |
|---|
| OG000 | Sensitivity - Proportion of Cytuity Cell Samples That Correctly Identify the Presence of Disease | The number of true positive Cytuity cell samples divided by the number of true positive and the number of false negatives | | OG001 | Specificity - Proportion of Cytuity Cell Samples That Correctly Identify the Absence of Disease | The number of true negative Cytuity cell samples divided by the number of true negatives and the number of false positives | | OG002 | PPV - Proportion of True Positive Results for Fallopian Tube Pathology | The proportion of positive Cytuity cell samples that came from a fallopian tube also found to have histology positive for malignancy |
|
| 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. | The number of Cytuity cell samples, not participants, was used for these endpoint analyses. | Posted | | Number | 95% Confidence Interval | Proportion of Cytuity Cell Samples | | At the time of the scheduled salpingectomy or salpingo-oophorectomy | Cytuity Cell Samples | Cytuity Cell Samples | | ID | Title | Description |
|---|
| OG000 | Sensitivity - Proportion of Cytuity Cell Samples That Correctly Identify the Presence of Disease | Number of true positive Cytuity cell samples divided by the number of true positives and the number of false negatives | | OG001 | Specificity - Proportion of Cytuity Cell Samples That Correctly Identify the Absence of Disease | The number of true negative Cytuity cell samples divided by the number of true negatives and the number of false positives | | OG002 | PPV - Proportion of True Positive Results for Ovary Pathology for Epithelial Malignancy | 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 |
|
| 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. | | Posted | | Count of Participants | | Participants | | At the time of the scheduled salpingectomy or salpingo-oophorectomy | | | | ID | Title | Description |
|---|
| OG000 | Sensitivity - Subjects in Which the Cytuity Correctly Identified the Presence of Disease | 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 | | OG001 | Specificity - Subjects in Which the Cytuity Correctly Identified the Absence 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 | | OG002 | PPV - True Positive Results for Fallopian Tube Involvement on Subject Level |
|