Clinical trial · Interventional
Evaluating the Performance of Morphology Index in Surgical Decision-Making for Ovarian Tumors
NCT02227654CI-TRIAL-00064404completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Neoplasms | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Abnormal Ovarian Ultrasound | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Abnormal Ovarian Ultrasound
- description
- Abnormal Ovarian Ultrasound
- interventionNames
- Procedure: Abnormal Ovarian Ultrasound
Primary outcomes (1)
- measure
- Positive predictive value (PPV) of ovarian cancer screening
- timeFrame
- Up to 12 months
- description
- 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.
Secondary outcomes (2)
- measure
- Surgical complications
- timeFrame
- Up to 12 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.