Fallopian Tube CancernCYTNCT03593681
Compare Fallopian Tube Cells Collected by Cytuity With Removed Ovarian/Tubal Tissue to Determine Presence of Malignancy
An observational study of Fallopian Tube Cancer and Ovarian Cancer, run by Boston Scientific Corporation at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fallopian Tube Cancer, Ovarian Cancer, Ovarian Neoplasms
- What is being tested?
- Hysteroscopic cell sampling of the fallopian tube
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 10 sitesUnited States
- Study dates
- 27 Aug 2018to 14 Feb 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who are scheduled to undergo a salpingo-oophorectomy or salpingectomy because of a pelvic mass suspicious for malignancy.
Who may be able to join
- Subject is medically cleared for surgery
- Subject is scheduled to undergo salpingo-oophorectomy or salpingectomy for a pelvic mass suspicious for malignancy
- Subject must be 18 years of age
- Subject must be able to provide informed consent
Who cannot join
- Contraindication to hysteroscopy
- Acute pelvic inflammatory disease
- Active or recent lower pelvic infection
- Pregnancy
- Delivery or termination of a pregnancy in the past 6 weeks
- Known tubal obstruction
Show all 9Show fewer
- Tubal ligation
- Invasive carcinoma of the cervix or endometrium
- Intolerance of anesthesia
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University of Virginia
Charlottesville, Virginia, 22908
Baylor Scott & White Research Institute
Fort Worth, Texas, 76104
Mayo Clinic
Jacksonville, Florida, 32224
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
New York Presbyterian Hospital
New York, New York, 10032
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107
Mayo Clinic
Rochester, Minnesota, 55905
Scripps Clinic Medical Group
San Diego, California, 92103
Kaiser Permanente San Francisco Medical Center
San Francisco, California, 94115
Swedish Health Services
Seattle, Washington, 98104
About this study
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
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.
- Conditions
- Fallopian Tube Cancer, Ovarian Cancer, Ovarian Neoplasms, Ovary Cancer, Fallopian Tube Neoplasms, Fallopian Tube Adenocarcinoma
- Being tested
- Hysteroscopic cell sampling of the fallopian tube
- Keywords
- salpingo-oophorectomy, salpingectomy, ovarian cancer, fallopian tube cancer, high grade serous carcinoma, hysteroscopic biopsy, fallopian tube cell collection, peritoneal cancer
- Medical subject headings
- Fallopian Tube Neoplasms, Ovarian Neoplasms, Peritoneal Neoplasms, Ovarian Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hysteroscopic cell sampling of the fallopian tubeDevice
Also called Cytuity
Hysteroscopic fallopian tube biopsy
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the time of the scheduled salpingectomy or salpingo-oophorectomy
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At the time of the scheduled salpingectomy or salpingo-oophorectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start27 Aug 2018
- Primary completion14 Feb 2020
- Study completion14 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Fallopian Tube CancerStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ted L Anderson, MD,PhD,FACOG, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03593681
- Sponsor's protocol ID
- CLIN 0507
- Acronym
- nCYT
- Status last verified
- Dec 2020
- First submitted
- 10 Jul 2018
- Last updated
- 20 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03593681
- Acronym / sponsor ID
- nCYT / CLIN 0507
- Conditions
- Fallopian Tube Cancer, Ovarian Cancer, Ovarian Neoplasms, Ovary Cancer, Fallopian Tube Neoplasms, Fallopian Tube Adenocarcinoma
- Keywords
- salpingo-oophorectomy, salpingectomy, ovarian cancer, fallopian tube cancer, high grade serous carcinoma, hysteroscopic biopsy, fallopian tube cell collection, peritoneal cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 27 Aug 2018 (actual)
- Primary completion
- 14 Feb 2020 (actual)
- Study completion
- 14 Feb 2020 (actual)
- First posted
- 20 Jul 2018 (actual)
- Results
- Posted 20 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who are scheduled to undergo a salpingo-oophorectomy or salpingectomy because of a pelvic mass suspicious for malignancy.
Key inclusion criteria (4 listed)
- Subject is medically cleared for surgery
- Subject is scheduled to undergo salpingo-oophorectomy or salpingectomy for a pelvic mass suspicious for malignancy
- Subject must be 18 years of age
- Subject must be able to provide informed consent
Key exclusion criteria (9 listed)
- Contraindication to hysteroscopy
- Acute pelvic inflammatory disease
- Active or recent lower pelvic infection
- Pregnancy
- Delivery or termination of a pregnancy in the past 6 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hysteroscopic cell sampling of the fallopian tubeAlso: CytuityHysteroscopic fallopian tube biopsy | Device | – |
Primary outcome
Sensitivity and Specificity of Cytological Samples for Fallopian Tube Involvement
Time frame: 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.
4 secondary outcomes
PPV, NPV and Diagnostic Accuracy for Fallopian Tube Involvement
Time frame: At the time of the scheduled salpingectomy or salpingo-oophorectomy
Sensitivity, Specificity, PPV, NPV and Diagnostic Accuracy 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
Time frame: At the time of the scheduled salpingectomy or salpingo-oophorectomy
Sensitivity, Specificity, PPV, NPV and Diagnostic Accuracy for Subject Level Analysis
Time frame: At the time of the scheduled salpingectomy or salpingo-oophorectomy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ted L Anderson, MD,PhD,FACOG principal investigator
Vanderbilt University Medical Center
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fallopian Tube Cancer and Ovarian Cancer, run by Boston Scientific Corporation at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and Specificity of Cytological Samples for Fallopian Tube Involvement (time frame: At the time of the scheduled salpingectomy or salpingo-oophorectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021; AzTrials last refreshed its copy on 7 Nov 2026.