Evaluating the Performance of Morphology Index in Surgical Decision-Making for Ovarian Tumors
| Status: | Recruiting |
|---|---|
| Conditions: | Ovarian Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 25 - Any |
| Updated: | 3/16/2019 |
| Start Date: | September 2016 |
| End Date: | August 2022 |
| Contact: | Frederick R. Ueland, M.D. |
| Email: | fuela0@uky.edu |
| Phone: | 859 257-1613 |
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.
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.
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.
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.
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.
We found this trial at
1
site
Lexington, Kentucky 40536
Principal Investigator: Frederick R. Ueland, M.D.
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