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

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03593681
• Collaborator: (none)
• Enrollment: 150
• Locations: 10
• Actual Duration (Months): 17.6
• Patients Per Site: 15
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
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	Device: Hysteroscopic cell sampling of the fallopian tube

Study Design

• Study Type: Observational
• Actual Enrollment: 150 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: 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
• Actual Study Start Date: Aug 27, 2018
• Actual Primary Completion Date: Feb 14, 2020
• Actual Study Completion Date: Feb 14, 2020

Outcome Measures

Primary Outcome Measures

1. Sensitivity and Specificity of Cytological Samples for Fallopian Tube Involvement [At the time of the scheduled salpingectomy or salpingo-oophorectomy]

   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.

Secondary Outcome Measures

1. PPV, NPV and Diagnostic Accuracy for Fallopian Tube Involvement [At the time of the scheduled salpingectomy or salpingo-oophorectomy]

   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.

2. Sensitivity, Specificity, PPV, NPV and Diagnostic Accuracy of the Fallopian Tube [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 of the fallopian tube.

3. Sensitivity, Specificity, PPV, NPV and Diagnostic Accuracy of the Ovaries [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 of the ovaries for epithelial malignancies.

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subject is medically cleared for surgery

2. Subject is scheduled to undergo salpingo-oophorectomy or salpingectomy for a pelvic mass suspicious for malignancy

3. Subject must be 18 years of age

4. Subject must be able to provide informed consent

Exclusion Criteria:

1. Contraindication to hysteroscopy

2. Acute pelvic inflammatory disease

3. Active or recent lower pelvic infection

4. Pregnancy

5. Delivery or termination of a pregnancy in the past 6 weeks

6. Known tubal obstruction

7. Tubal ligation

8. Invasive carcinoma of the cervix or endometrium

9. Intolerance of anesthesia

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Scripps Clinic Medical Group	San Diego	California	United States	92103
2	Kaiser Permanente San Francisco Medical Center	San Francisco	California	United States	94115
3	Mayo Clinic	Jacksonville	Florida	United States	32224
4	Mayo Clinic	Rochester	Minnesota	United States	55905
5	New York Presbyterian Hospital	New York	New York	United States	10032
6	Pennsylvania Hospital	Philadelphia	Pennsylvania	United States	19107
7	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37232
8	Baylor Scott & White Research Institute	Fort Worth	Texas	United States	76104
9	University of Virginia	Charlottesville	Virginia	United States	22908
10	Swedish Health Services	Seattle	Washington	United States	98104

Sponsors and Collaborators

• Boston Scientific Corporation

Investigators

• Principal Investigator: Ted L Anderson, MD,PhD,FACOG, Vanderbilt University Medical Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 22, 2019

More Information

Publications

None provided.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT03593681
• Other Study ID Numbers: CLIN 0507
• First Posted: Jul 20, 2018
• Last Update Posted: Jan 20, 2021
• Last Verified: Dec 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Boston Scientific Corporation: salpingo-oophorectomy; salpingectomy; ovarian cancer; fallopian tube cancer; high grade serous carcinoma; hysteroscopic biopsy; fallopian tube cell collection; peritoneal cancer
• Additional relevant MeSH terms: Carcinoma; Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Cystadenocarcinoma, Serous; Peritoneal Neoplasms; Ovarian Diseases

Study Results

Participant Flow

Arm/Group Title	Cytuity Cytological Evaluation
Arm/Group Description	Those subjects enrolled in the study, with hysteroscope placed, ostia visualized, and adequate Cytuity cell sample collected.
Period Title: Overall Study
STARTED	150
COMPLETED	115
NOT COMPLETED	35

Baseline Characteristics

Arm/Group Title	Cytuity Cytological Evaluation
Arm/Group Description	Subjects from whom a signed informed consent form was obtained.
Overall Participants	150
Age (years) [Mean (Standard Deviation) ]
Age at Baseline	53.9 (14.1)
Sex: Female, Male (Count of Participants)
Female	150 100%
Male	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.7%
Asian	9 6%
Native Hawaiian or Other Pacific Islander	2 1.3%
Black or African American	3 2%
White	125 83.3%
More than one race	0 0%
Unknown or Not Reported	10 6.7%
Height (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	162.8 (7.9)
Weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	77.2 (21.3)
BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	29.1 (7.7)

Outcome Measures

1. Primary Outcome

Title	Sensitivity and Specificity of Cytological Samples for Fallopian Tube Involvement
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Sensitivity - Proportion of Cytuity Cell Samples That Correctly Identify the Presence of Disease	Specificity - Proportion of Cytuity Cell Samples That Correctly Identify the Absence of Disease
Arm/Group Description	The number of true positive Cytuity cell samples divided by the number of true positives 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.
Measure Participants	NA	NA
Measure Cytuity Cell Samples	14	156
Number (95% Confidence Interval) [Proportion of Cytuity Cell Samples]	.143	.959

2. Secondary Outcome

Title	PPV, NPV and Diagnostic Accuracy for Fallopian Tube Involvement
Description	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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	PPV - Proportion of True Positive Results for Fallopian Tube Involvement	NPV - Proportion of True Negative Results for Fallopian Tube Involvement	Diagnostic Accuracy - Proportion of Accurate Diagnoses
Arm/Group Description	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	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	The proportion of Cytuity cell sample results that conformed to the correct diagnosis as determined by the surgical histology results
Measure Participants	NA	NA	NA
Measure Cytuity Cell Samples	9	161	170
Number (95% Confidence Interval) [Proportion of Cytuity Cell Samples]	0.221	0.932	.894

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Sensitivity - Proportion of Cytuity Cell Samples That Correctly Identify the Presence of Disease	Specificity - Proportion of Cytuity Cell Samples That Correctly Identify the Absence of Disease	PPV - Proportion of True Positive Results for Fallopian Tube Pathology	NPV - Proportion of True Negative Results for Fallopian Tube Pathology	Diagnostic Accuracy - Proportion of Accurate Diagnoses
Arm/Group Description	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	The proportion of negative Cytuity cell samples that came from a fallopian tube also found to have histology negative for malignancy	The proportion of Cytuity cell sample results that conformed to the correct diagnosis as determined by the surgical histology results
Measure Participants	NA	NA	NA	NA	NA
Measure Cytuity Cell Samples	13	157	9	161	170
Number (95% Confidence Interval) [Proportion of Cytuity Cell Samples]	.077	.952	.108	.932	.888

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Sensitivity - Proportion of Cytuity Cell Samples That Correctly Identify the Presence of Disease	Specificity - Proportion of Cytuity Cell Samples That Correctly Identify the Absence of Disease	PPV - Proportion of True Positive Results for Ovary Pathology for Epithelial Malignancy	NPV - Proportion of True Negatives for Ovary Pathology for Epithelial Malignancy	Diagnostic Accuracy - Proportion of Accurate Diagnoses
Arm/Group Description	Number of true positive Cytuity cell samples divided by the number of true positives 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 adjacent to a corresponding ovary found to have histology positive for 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	The proportion of Cytuity cell sample results that conformed to the correct diagnosis as determined by the surgical histology results
Measure Participants	NA	NA	NA	NA	NA
Measure Cytuity Cell Samples	22	135	7	150	157
Number (95% Confidence Interval) [Proportion of Cytuity Cell Samples]	.091	.963	.281	.883	.851

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sensitivity - Subjects in Which the Cytuity Correctly Identified the Presence of Disease	Specificity - Subjects in Which the Cytuity Correctly Identified the Absence of Disease	PPV - True Positive Results for Fallopian Tube Involvement on Subject Level	NPV - True Negative Results for Fallopian Tube Involvement on Subject Level	Diagnostic Accuracy - Subjects With Accurate Diagnoses
Arm/Group Description	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	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	The number of subjects with a positive Cytuity cell sample and a fallopian tube and/or corresponding ovary with histology positive for malignancy	The number of subjects with a negative Cytuity cell sample and a fallopian tube and corresponding ovary with histology negative for malignancy	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
Measure Participants	10	64	8	66	74
Count of Participants [Participants]	2 1.3%	58 NaN	2 NaN	58 NaN	60 NaN

Adverse Events

Time Frame	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).
Arm/Group Title	Treated Subjects
Arm/Group Description	Subjects who signed the informed consent and had hysteroscope placement attempted
All Cause Mortality
	Treated Subjects
	Affected / at Risk (%)	# Events
Total	0/130 (0%)
Serious Adverse Events
	Treated Subjects
	Affected / at Risk (%)	# Events
Total	3/130 (2.3%)
Blood and lymphatic system disorders
Anemia	1/130 (0.8%)	1
Gastrointestinal disorders
Intra-abdominal hemorrhage	1/130 (0.8%)	1
Renal and urinary disorders
Acute Kidney Injury	1/130 (0.8%)	1
Other (Not Including Serious) Adverse Events
	Treated Subjects
	Affected / at Risk (%)	# Events
Total	2/130 (1.5%)
Injury, poisoning and procedural complications
Uterine Perforation	1/130 (0.8%)	1
Fallopian Tube perforation	1/130 (0.8%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.