Clinical trial NCT02227654: Evaluating the Performance of Morphology Index in Surgical Decision-Making for Ovarian Tumors
Official title: Evaluating the Performance of Morphology Index in Surgical Decision-Making for Ovarian Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovarian Neoplasms
Keywords: Ovary
Cancer
Morphology
Surgery
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: Lucille P. Markey Cancer Center at University of Kentucky
First posted: 2014-08-28
Enrollment: 179
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Positive predictive value (PPV) of ovarian cancer screening
timeFrame: Up to 12 months
Secondary outcomes:
measure: Surgical complications
timeFrame: Up to 12 months
measure: Compliance to the treatment algorithm
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Markey Cancer Center, University of Kentucky
state: Kentucky
Study officials:
affiliation: Markey Cancer Center, University of Kentucky
name: Frederick R. Ueland, M.D.
role: PRINCIPAL_INVESTIGATOR
References: