Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Ovarian Cancer

Abnormal Ovarian Ultrasound

Frederick R. Ueland, M.D.

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.

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.

Evaluating the Performance of Morphology Index in Surgical Decision-Making for Ovarian Tumors

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.

Surgical complications including type, severity, and resolution.

Percentage of required visits that were attended for each individual's treatment algorithm

Lucille P. Markey Cancer Center at University of Kentucky

Principal Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Evaluating the Performance of Morphology Index in Surgical Decision-Making for Ovarian Tumors	NCT02227654	Ovarian Neoplas...	Abnormal Ovaria...	25 Years -	University of Kentucky
Evaluating the Performance of Morphology Index in Surgical Decision-Making for Ovarian Tumors	NCT02227654	Ovarian Neoplas...	Abnormal Ovaria...	25 Years -	University of Kentucky

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