Ovarian NeoplasmsNCT02227654
Evaluating the Performance of Morphology Index in Surgical Decision-Making for Ovarian Tumors
A study testing Abnormal Ovarian Ultrasound in people with Ovarian Neoplasms, run by Frederick R. Ueland, M.D. at 1 site in United States.
Trial summary
The present investigation will prospectively evaluate whether serial transvaginal ultrasonography with Morphology Index (MI) can further reduce false positive results by more accurately distinguishing benign from malignant ovarian tumors. Read more about this study
- Who is it for?
- Ages 25 years and older, women only
- Conditions the study is for
- Ovarian Neoplasms
- What is being tested?
- Abnormal Ovarian Ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2016to 7 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women must be enrolled in the University of Kentucky Ovarian Cancer Screening Program Eligibility criteria for the OCSP are: 50 years of age or older, or be postmenopausal and have not had a prior salpingo-oophorectomy or have a family history of ovarian cancer in a primary relative or have a self-history of breast cancer.
- Patients have a documented ovarian abnormality on ultrasound
- Patients having undergone prior hysterectomy will be eligible provided that they meet the other requirements for entry into this study.
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Patients who are not enrolled in the University of Kentucky Ovarian Cancer Screening Program .
- Patients who cannot tolerate the vaginal ultrasound procedure.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients who are referred with pelvic symptoms, a known pelvic mass, or a history of prior radiation, will be excluded from this investigation.
- History of ovarian cancer.
- Prior bilateral salpingo-oophorectomy.
- Prisoners.
- Women who are currently pregnant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Markey Cancer Center, University of Kentucky
Lexington, Kentucky, 40536
About this study
The present investigation will prospectively evaluate whether serial transvaginal ultrasonography with Morphology Index (MI) can further reduce false positive results by more accurately distinguishing benign from malignant ovarian tumors. If there is no change in the detection of true positive cases, the result will be an increase in the positive predictive value of ovarian cancer screening.
Read the detailed description
Primary Objective:
To determine if a treatment algorithm using serial transvaginal ultrasound with a tumor morphology index can improve the positive predictive value (PPV) of ovarian cancer screening compared to a historical control from 15% to 25%.
Secondary Objective To measure the compliance for study participants enrolled on the treatment algorithm using serial transvaginal ultrasound with a tumor morphology index.
Exploratory Objective To determine the effectiveness of a treatment algorithm that combines serum biomarkers aloneor in combination with transvaginal ultrasound to reduce the false positive rate of ovarian cancer screening in the subset of women agreeing to biomarker collection.
- Conditions
- Ovarian Neoplasms
- Being tested
- Abnormal Ovarian Ultrasound
- Keywords
- Ovary, Cancer, Morphology, Surgery
- Medical subject headings
- Ovarian Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abnormal Ovarian UltrasoundProcedure or surgery
Ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Abnormal Ovarian Ultrasound | Experimental | Abnormal Ovarian Ultrasound Receives: Procedure: Abnormal Ovarian Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive predictive value (PPV) of ovarian cancer screening
Whether the treatment algorithm for patients with abnormal ultrasounds improves the positive predictive value of ultrasounds as ovarian screening tests, thus lowering the false positive rate compared to historical controls.
Measured: Up to 12 months
Secondary outcomes (2)
Surgical complications
Surgical complications including type, severity, and resolution.
Measured: Up to 12 months
Compliance to the treatment algorithm
Percentage of required visits that were attended for each individual's treatment algorithm
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2014 (estimated)
- Study start12 Sep 2016
- Primary completion7 Sep 2022
- Study completion7 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frederick R. Ueland, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Lucille P. Markey Cancer Center at University of Kentucky
- Responsible party
- Sponsor-investigator, Frederick R. Ueland, M.D., University of Kentucky
- Investigators
- Frederick R. Ueland, M.D., Principal investigator, Markey Cancer Center, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02227654
- Sponsor's protocol ID
- 14-GYN-200
- Status last verified
- Feb 2023
- First submitted
- 26 Aug 2014
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Performance of Morphology Index in Surgical Decision-Making for Ovarian Tumors
- ClinicalTrials.gov ID
- NCT02227654
- Acronym / sponsor ID
- 14-GYN-200
- Conditions
- Ovarian Neoplasms
- Keywords
- Ovary, Cancer, Morphology, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- Frederick R. Ueland, M.D.University, hospital or other
- Collaborators
- Lucille P. Markey Cancer Center at University of Kentucky
- Study start
- 12 Sep 2016 (actual)
- Primary completion
- 7 Sep 2022 (actual)
- Study completion
- 7 Sep 2022 (actual)
- First posted
- 28 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present investigation will prospectively evaluate whether serial transvaginal ultrasonography with Morphology Index (MI) can further reduce false positive results by more accurately distinguishing benign from malignant ovarian tumors. If there is no change in the detection of true positive cases, the result will be an increase in the positive predictive value of ovarian cancer screening.
Detailed description
Primary Objective:
To determine if a treatment algorithm using serial transvaginal ultrasound with a tumor morphology index can improve the positive predictive value (PPV) of ovarian cancer screening compared to a historical control from 15% to 25%.
Secondary Objective To measure the compliance for study participants enrolled on the treatment algorithm using serial transvaginal ultrasound with a tumor morphology index.
Exploratory Objective To determine the effectiveness of a treatment algorithm that combines serum biomarkers aloneor in combination with transvaginal ultrasound to reduce the false positive rate of ovarian cancer screening in the subset of women agreeing to biomarker collection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abnormal Ovarian Ultrasound | Experimental | Procedure: Abnormal Ovarian UltrasoundAbnormal Ovarian Ultrasound |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women must be enrolled in the University of Kentucky Ovarian Cancer Screening Program Eligibility criteria for the OCSP are: 50 years of age or older, or be postmenopausal and have not had a prior salpingo-oophorectomy or have a family history of ovarian cancer in a primary relative or have a self-history of breast cancer.
- Patients have a documented ovarian abnormality on ultrasound
- Patients having undergone prior hysterectomy will be eligible provided that they meet the other requirements for entry into this study.
- Ability to understand and the willingness to sign a written informed consent document
Key exclusion criteria (8 listed)
- Patients who are not enrolled in the University of Kentucky Ovarian Cancer Screening Program .
- Patients who cannot tolerate the vaginal ultrasound procedure.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients who are referred with pelvic symptoms, a known pelvic mass, or a history of prior radiation, will be excluded from this investigation.
- History of ovarian cancer.
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 |
|---|---|---|
| Abnormal Ovarian UltrasoundUltrasound | Procedure or surgery | Abnormal Ovarian Ultrasound |
Primary outcome
Positive predictive value (PPV) of ovarian cancer screening
Time frame: Up to 12 months
Whether the treatment algorithm for patients with abnormal ultrasounds improves the positive predictive value of ultrasounds as ovarian screening tests, thus lowering the false positive rate compared to historical controls.
2 secondary outcomes
Surgical complications
Time frame: Up to 12 months
Compliance to the treatment algorithm
Time frame: Up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Frederick R. Ueland, M.D. principal investigator
Markey Cancer Center, University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abnormal Ovarian Ultrasound in people with Ovarian Neoplasms, run by Frederick R. Ueland, M.D. at 1 site 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 8 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 2 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Positive predictive value (PPV) of ovarian cancer screening (time frame: Up to 12 months). 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 2 Mar 2023.