Clinical trial NCT03593681: Compare Fallopian Tube Cells Collected by Cytuity With Removed Ovarian/Tubal Tissue to Determine Presence of Malignancy
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: 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
Keywords: salpingo-oophorectomy
salpingectomy
ovarian cancer
fallopian tube cancer
high grade serous carcinoma
hysteroscopic biopsy
fallopian tube cell collection
peritoneal cancer
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2018-07-20
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who are scheduled to undergo a salpingo-oophorectomy or salpingectomy because of a pelvic mass suspicious for malignancy.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity and Specificity of Cytological Samples for Fallopian Tube Involvement
timeFrame: At the time of the scheduled salpingectomy or salpingo-oophorectomy
Secondary outcomes:
measure: PPV, NPV and Diagnostic Accuracy for Fallopian Tube Involvement
timeFrame: At the time of the scheduled salpingectomy or salpingo-oophorectomy
measure: Sensitivity, Specificity, PPV, NPV and Diagnostic Accuracy of the Fallopian Tube
timeFrame: At the time of the scheduled salpingectomy or salpingo-oophorectomy
measure: Sensitivity, Specificity, PPV, NPV and Diagnostic Accuracy of the Ovaries
timeFrame: At the time of the scheduled salpingectomy or salpingo-oophorectomy
measure: Sensitivity, Specificity, PPV, NPV and Diagnostic Accuracy for Subject Level Analysis
timeFrame: At the time of the scheduled salpingectomy or salpingo-oophorectomy
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Scripps Clinic Medical Group
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente San Francisco Medical Center
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: New York Presbyterian Hospital
state: New York
city: Philadelphia
country: United States
facility: Pennsylvania Hospital
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Fort Worth
country: United States
facility: Baylor Scott & White Research Institute
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Seattle
country: United States
facility: Swedish Health Services
state: Washington
Study officials:
affiliation: Vanderbilt University Medical Center
name: Ted L Anderson, MD,PhD,FACOG
role: PRINCIPAL_INVESTIGATOR
References: