Ovarian Neoplasms
Conditions
Keywords
Ovary, Cancer, Morphology, Surgery
Brief 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. 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.
Interventions
PROCEDUREAbnormal Ovarian Ultrasound
Ultrasound
Sponsors
Lucille P. Markey Cancer Center at University of Kentucky
Frederick R. Ueland, M.D.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive predictive value (PPV) of ovarian cancer screening | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical complications | Up to 12 months | Surgical complications including type, severity, and resolution. |
| Compliance to the treatment algorithm | Up to 12 months | Percentage of required visits that were attended for each individual's treatment algorithm |
Countries
United States
Outcome results
None listed