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.
Study Type
OBSERVATIONAL
Enrollment
150
Hysteroscopic fallopian tube biopsy
Scripps Clinic Medical Group
San Diego, California, United States
Kaiser Permanente San Francisco Medical Center
San Francisco, California, United States
Mayo Clinic
Jacksonville, Florida, 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
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.
Time frame: At the time of the scheduled salpingectomy or salpingo-oophorectomy
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At the time of the scheduled salpingectomy or salpingo-oophorectomy
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