A 2‐stage ovarian cancer screening strategy using the Risk of Ovarian Cancer Algorithm (ROCA) identifies early‐stage incident cancers and demonstrates high positive predictive value

Abstract

Background We evaluated a two stage ovarian cancer screening strategy that incorporates change of CA 125 over time and age to estimate risk of ovarian cancer. Women with high risk scores were referred for transvaginal ultrasound (TVS). Methods A single-arm, prospective study of post-menopausal women was conducted. Participants underwent an annual CA 125 blood test. Based on the Risk of Ovarian Cancer Algorithm (ROCA) result, women were triaged to next annual CA 125 (low risk), repeat CA 125 in three months (intermediate risk), or TVS and referral to a gynecologic oncologist (high risk). Results 4051 women participated over 11 years. The average annual rate of referral to a CA125 in three months was 5.8%, and the average annual referral rate to TVS and review by a gynecologic oncologist was 0.9%. Ten women underwent surgery based on TVS, with four invasive ovarian cancers (one Stage 1A, two Stage 1C and one Stage IIB), two ovarian tumors of low malignant potential (both Stage 1A), one endometrial cancer (Stage 1), and three benign ovarian tumors, providing a positive predictive value of 40% (95% CI 12.2%, 73.8%) for detecting invasive ovarian cancer. The specificity was 99.9% (95% CI 99.7%, 100%). All four women with invasive ovarian cancer were enrolled in the study for at least three years with low risk, annual CA 125 values prior to a rising CA 125. Conclusions ROCA followed by TVS demonstrated excellent specificity and PPV in a population of U.S. women at average risk for ovarian cancer.

A Multiplexable, Microfluidic Platform for the Rapid Quantitation of a Biomarker Panel for Early Ovarian Cancer Detection at the Point-of-Care

“…To evaluate the clinical performance of the p-BNC multiplexed system, sera from healthy individuals (n=7), patients with benign gynecological conditions (n=8), patients with early-stage ovarian cancer (n=7), and patients with late-stage ovarian cancer (n=9) were assayed. To test the potential of the p-BNC to assay sequential samples from the same women, plasma samples were assayed that had been collected at multiple (2–12) time points from women who had remained healthy (n=4) and who had developed ovarian cancer (n=2) during the course of the study. Samples were acquired from the MD Anderson Normal Risk Ovarian Cancer Study (NROS) Study Serum Bank (12).…”

“…To test the potential of the p-BNC to assay sequential samples from the same women, plasma samples were assayed that had been collected at multiple (2–12) time points from women who had remained healthy (n=4) and who had developed ovarian cancer (n=2) during the course of the study. Samples were acquired from the MD Anderson Normal Risk Ovarian Cancer Study (NROS) Study Serum Bank (12). All samples were thawed at 4°C before use and diluted two-fold in SuperBlock (PBS) Buffer prior to analysis on the p-BNC.…”

“…Despite the clear correlation of elevated CA125 levels to the growth of many ovarian cancers, clinical utility for early detection remains to be established (5,9). A two-stage screening strategy that utilizes rising CA125 to prompt TVS in a small fraction of women is being evaluated by the United Kingdom Collaborative trial of Ovarian Cancer Screening (UKCTOCS) and a Normal Risk Ovarian Cancer Screening Trial in the United States (10–12). Both trials indicate that no more than three operations will be required to detect each case of ovarian cancer (11,12).…”

“…A two-stage screening strategy that utilizes rising CA125 to prompt TVS in a small fraction of women is being evaluated by the United Kingdom Collaborative trial of Ovarian Cancer Screening (UKCTOCS) and a Normal Risk Ovarian Cancer Screening Trial in the United States (10–12). Both trials indicate that no more than three operations will be required to detect each case of ovarian cancer (11,12). While the specificity is adequate, it remains to be seen whether adequate sensitivity can be achieved.…”

Overexpression of SIRT1 is Associated With Poor Outcomes in Patients With Ovarian Carcinoma

“…3 OvCa primarily causes higher cancer mortality because it presents with nonspecific symptoms and most patients present with advanced stages such that the cure rate is low. 4 Despite advances in treatments, the 5-year survival has not changed significantly over the years. 5 Recurrence and drug resistance are common results of treatment failures.…”