Trial Outcomes & Findings for Compare Fallopian Tube Cells Collected by Cytuity With Removed Ovarian/Tubal Tissue to Determine Presence of Malignancy (NCT NCT03593681)

NCT ID: NCT03593681

Last Updated: 2021-01-20

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 150 participants
• Primary outcome timeframe: At the time of the scheduled salpingectomy or salpingo-oophorectomy
• Results posted on: 2021-01-20

Participant Flow

Participant milestones

Measure	Cytuity Cytological Evaluation Those subjects enrolled in the study, with hysteroscope placed, ostia visualized, and adequate Cytuity cell sample collected.
Overall Study STARTED	150
Overall Study COMPLETED	115
Overall Study NOT COMPLETED	35

Reasons for withdrawal

Measure	Cytuity Cytological Evaluation Those subjects enrolled in the study, with hysteroscope placed, ostia visualized, and adequate Cytuity cell sample collected.
Overall Study Inadequate sample collected	12
Overall Study Hysteroscope attempted but unable to find ostia	11
Overall Study Protocol Violation	3
Overall Study Withdrawal by Subject	3
Overall Study Procedure not attempted	3
Overall Study Adverse Event	2
Overall Study Physician Decision	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Cytuity Cytological Evaluation n=150 Participants Subjects from whom a signed informed consent form was obtained.
Age, Continuous Age at Baseline	53.9 years STANDARD_DEVIATION 14.1 • n=5 Participants
Sex: Female, Male Female	150 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	9 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	125 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants
Height	162.8 cm STANDARD_DEVIATION 7.9 • n=5 Participants
Weight	77.2 kg STANDARD_DEVIATION 21.3 • n=5 Participants
BMI	29.1 kg/m^2 STANDARD_DEVIATION 7.7 • n=5 Participants

PRIMARY outcome

Timeframe: At the time of the scheduled salpingectomy or salpingo-oophorectomy

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

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.

Outcome measures

Measure	Sensitivity - Proportion of Cytuity Cell Samples That Correctly Identify the Presence of Disease n=14 Cytuity Cell Samples The number of true positive Cytuity cell samples divided by the number of true positives and the number of false negatives.	Specificity - Proportion of Cytuity Cell Samples That Correctly Identify the Absence of Disease n=156 Cytuity Cell Samples The number of true negative Cytuity cell samples divided by the number of true negatives and the number of false positives.	Diagnostic Accuracy - Proportion of Accurate Diagnoses The proportion of Cytuity cell sample results that conformed to the correct diagnosis as determined by the surgical histology results	NPV - Proportion of True Negative 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	Diagnostic Accuracy - Proportion of Accurate Diagnoses The proportion of Cytuity cell sample results that conformed to the correct diagnosis as determined by the surgical histology results
Sensitivity and Specificity of Cytological Samples for Fallopian Tube Involvement	.143 Proportion of Cytuity Cell Samples Interval 0.029 to 0.479	.959 Proportion of Cytuity Cell Samples Interval 0.911 to 0.981	—	—	—

SECONDARY outcome

Timeframe: At the time of the scheduled salpingectomy or salpingo-oophorectomy

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

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.

Outcome measures

Measure	Sensitivity - Proportion of Cytuity Cell Samples That Correctly Identify the Presence of Disease n=9 Cytuity Cell Samples The number of true positive Cytuity cell samples divided by the number of true positives and the number of false negatives.	Specificity - Proportion of Cytuity Cell Samples That Correctly Identify the Absence of Disease n=161 Cytuity Cell Samples The number of true negative Cytuity cell samples divided by the number of true negatives and the number of false positives.	Diagnostic Accuracy - Proportion of Accurate Diagnoses n=170 Cytuity Cell Samples The proportion of Cytuity cell sample results that conformed to the correct diagnosis as determined by the surgical histology results	NPV - Proportion of True Negative 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	Diagnostic Accuracy - Proportion of Accurate Diagnoses The proportion of Cytuity cell sample results that conformed to the correct diagnosis as determined by the surgical histology results
PPV, NPV and Diagnostic Accuracy for Fallopian Tube Involvement	0.221 Proportion of Cytuity Cell Samples Interval 0.032 to 0.71	0.932 Proportion of Cytuity Cell Samples Interval 0.877 to 0.963	.894 Proportion of Cytuity Cell Samples Interval 0.834 to 0.934	—	—

SECONDARY outcome

Timeframe: At the time of the scheduled salpingectomy or salpingo-oophorectomy

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

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.

Outcome measures

Measure	Sensitivity - Proportion of Cytuity Cell Samples That Correctly Identify the Presence of Disease n=13 Cytuity Cell Samples The number of true positive Cytuity cell samples divided by the number of true positives and the number of false negatives.	Specificity - Proportion of Cytuity Cell Samples That Correctly Identify the Absence of Disease n=157 Cytuity Cell Samples The number of true negative Cytuity cell samples divided by the number of true negatives and the number of false positives.	Diagnostic Accuracy - Proportion of Accurate Diagnoses n=9 Cytuity Cell Samples The proportion of Cytuity cell sample results that conformed to the correct diagnosis as determined by the surgical histology results	NPV - Proportion of True Negative Results for Fallopian Tube Pathology n=161 Cytuity Cell Samples The proportion of negative Cytuity cell samples that came from a fallopian tube also found to have histology negative for malignancy	Diagnostic Accuracy - Proportion of Accurate Diagnoses n=170 Cytuity Cell Samples The proportion of Cytuity cell sample results that conformed to the correct diagnosis as determined by the surgical histology results
Sensitivity, Specificity, PPV, NPV and Diagnostic Accuracy of the Fallopian Tube	.077 Proportion of Cytuity Cell Samples Interval 0.008 to 0.467	.952 Proportion of Cytuity Cell Samples Interval 0.903 to 0.977	.108 Proportion of Cytuity Cell Samples Interval 0.008 to 0.652	.932 Proportion of Cytuity Cell Samples Interval 0.877 to 0.963	.888 Proportion of Cytuity Cell Samples Interval 0.826 to 0.929

SECONDARY outcome

Timeframe: At the time of the scheduled salpingectomy or salpingo-oophorectomy

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

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.

Outcome measures

Measure	Sensitivity - Proportion of Cytuity Cell Samples That Correctly Identify the Presence of Disease n=22 Cytuity Cell Samples The number of true positive Cytuity cell samples divided by the number of true positives and the number of false negatives.	Specificity - Proportion of Cytuity Cell Samples That Correctly Identify the Absence of Disease n=135 Cytuity Cell Samples The number of true negative Cytuity cell samples divided by the number of true negatives and the number of false positives.	Diagnostic Accuracy - Proportion of Accurate Diagnoses n=7 Cytuity Cell Samples The proportion of Cytuity cell sample results that conformed to the correct diagnosis as determined by the surgical histology results	NPV - Proportion of True Negative Results for Fallopian Tube Pathology n=150 Cytuity Cell Samples The proportion of negative Cytuity cell samples that came from a fallopian tube also found to have histology negative for malignancy	Diagnostic Accuracy - Proportion of Accurate Diagnoses n=157 Cytuity Cell Samples The proportion of Cytuity cell sample results that conformed to the correct diagnosis as determined by the surgical histology results
Sensitivity, Specificity, PPV, NPV and Diagnostic Accuracy of the Ovaries	.091 Proportion of Cytuity Cell Samples Interval 0.02 to 0.331	.963 Proportion of Cytuity Cell Samples Interval 0.913 to 0.985	.281 Proportion of Cytuity Cell Samples Interval 0.04 to 0.788	.883 Proportion of Cytuity Cell Samples Interval 0.812 to 0.929	.851 Proportion of Cytuity Cell Samples Interval 0.779 to 0.902

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Sensitivity - Proportion of Cytuity Cell Samples That Correctly Identify the Presence of Disease n=10 Participants The number of true positive Cytuity cell samples divided by the number of true positives and the number of false negatives.	Specificity - Proportion of Cytuity Cell Samples That Correctly Identify the Absence of Disease n=64 Participants The number of true negative Cytuity cell samples divided by the number of true negatives and the number of false positives.	Diagnostic Accuracy - Proportion of Accurate Diagnoses n=8 Participants The proportion of Cytuity cell sample results that conformed to the correct diagnosis as determined by the surgical histology results	NPV - Proportion of True Negative Results for Fallopian Tube Pathology n=66 Participants The proportion of negative Cytuity cell samples that came from a fallopian tube also found to have histology negative for malignancy	Diagnostic Accuracy - Proportion of Accurate Diagnoses n=74 Participants The proportion of Cytuity cell sample results that conformed to the correct diagnosis as determined by the surgical histology results
Sensitivity, Specificity, PPV, NPV and Diagnostic Accuracy for Subject Level Analysis	2 Participants	58 Participants	2 Participants	58 Participants	60 Participants

Adverse Events

Treated Subjects

Serious events: 3 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treated Subjects n=130 participants at risk Subjects who signed the informed consent and had hysteroscope placement attempted
Blood and lymphatic system disorders Anemia	0.77% 1/130 • Number of events 1 • Adverse events occurring from the time the hysteroscope entered the subject until study exit (defined as 24 hours post-Cytuity use or discharge, whichever occurs first).
Gastrointestinal disorders Intra-abdominal hemorrhage	0.77% 1/130 • Number of events 1 • Adverse events occurring from the time the hysteroscope entered the subject until study exit (defined as 24 hours post-Cytuity use or discharge, whichever occurs first).
Renal and urinary disorders Acute Kidney Injury	0.77% 1/130 • Number of events 1 • Adverse events occurring from the time the hysteroscope entered the subject until study exit (defined as 24 hours post-Cytuity use or discharge, whichever occurs first).

Other adverse events

Measure	Treated Subjects n=130 participants at risk Subjects who signed the informed consent and had hysteroscope placement attempted
Injury, poisoning and procedural complications Uterine Perforation	0.77% 1/130 • Number of events 1 • Adverse events occurring from the time the hysteroscope entered the subject until study exit (defined as 24 hours post-Cytuity use or discharge, whichever occurs first).
Injury, poisoning and procedural complications Fallopian Tube perforation	0.77% 1/130 • Number of events 1 • Adverse events occurring from the time the hysteroscope entered the subject until study exit (defined as 24 hours post-Cytuity use or discharge, whichever occurs first).

Additional Information

Clinical Trial Project Manager

Boston Scientific

Phone: 612-209-9532

Email: blake.hedstrom@bsci.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60