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| Name | Class |
|---|---|
| Lucille P. Markey Cancer Center at University of Kentucky | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abnormal Ovarian Ultrasound | Experimental | Abnormal Ovarian Ultrasound |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abnormal Ovarian Ultrasound | Procedure | Ultrasound |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical complications | Surgical complications including type, severity, and resolution. | Up to 12 months |
| Compliance to the treatment algorithm | Percentage of required visits that were attended for each individual's treatment algorithm |
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Inclusion Criteria:
Exclusion Criteria:
Because ovarian cancer is a disease of only women, men are not included in this study, but women of all races and ethnic groups are eligible for this trial.
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| Name | Affiliation | Role |
|---|---|---|
| Frederick R. Ueland, M.D. | Markey Cancer Center, University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Markey Cancer Center, University of Kentucky | Lexington | Kentucky | 40536 | United States |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
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| Up to 12 months |
| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |