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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03593681

Acronym

nCYT

Enrollment

150

Registered

2018-07-20

Start date

2018-08-27

Completion date

2020-02-14

Last updated

2021-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adnexal Mass, Fallopian Tube Adenocarcinoma, Fallopian Tube Cancer, Fallopian Tube Neoplasms, High Grade Serous Carcinoma, Ovarian Cancer, Ovarian Diseases, Ovarian Neoplasms, Ovary Cancer, Peritoneal Carcinoma, Peritoneal Neoplasms

Keywords

salpingo-oophorectomy, salpingectomy, ovarian cancer, fallopian tube cancer, high grade serous carcinoma, hysteroscopic biopsy, fallopian tube cell collection, peritoneal cancer

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.

Interventions

DEVICEHysteroscopic cell sampling of the fallopian tube

Hysteroscopic fallopian tube biopsy

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.
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.
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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Cytuity Cytological Evaluation Subjects from whom a signed informed consent form was obtained.	150
Total	150

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	2
Overall Study	Hysteroscope attempted but unable to find ostia	11
Overall Study	Inadequate sample collected	12
Overall Study	Physician Decision	1
Overall Study	Procedure not attempted	3
Overall Study	Protocol Violation	3
Overall Study	Withdrawal by Subject	3

Baseline characteristics

Characteristic	Cytuity Cytological Evaluation
Age, Continuous Age at Baseline	53.9 years STANDARD_DEVIATION 14.1
BMI	29.1 kg/m^2 STANDARD_DEVIATION 7.7
Height	162.8 cm STANDARD_DEVIATION 7.9
Race (NIH/OMB) American Indian or Alaska Native	1 Participants
Race (NIH/OMB) Asian	9 Participants
Race (NIH/OMB) Black or African American	3 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants
Race (NIH/OMB) Unknown or Not Reported	10 Participants
Race (NIH/OMB) White	125 Participants
Sex: Female, Male Female	150 Participants
Sex: Female, Male Male	0 Participants
Weight	77.2 kg STANDARD_DEVIATION 21.3

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 130
other Total, other adverse events	2 / 130
serious Total, serious adverse events	3 / 130

Outcome results

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.