Introduction/Background ROCkeTS investigated accuracy of risk prediction models for diagnosing ovarian cancer (OC); no previous studies investigate all tests as head-to-head comparisons.

Methodology Recruitment: ROCkeTS recruited newly presenting women with non-specific symptoms and raised CA125 and/or abnormal imaging to donate blood and undergo ultrasound scan performed mainly by sonographers. Sonographers achieved certification in IOTA models pre-participation and underwent quality assurance.

Index tests: IOTA ADNeX model 3% and 10% thresholds, RMI1 at 200, ROMA at >14.4%, >25.3%, >27.7%, > 29.9% (manufacturer recommended threshold) and CA125 at 35 IU/ml.

Comparator: RMI1 at 250 threshold.

Reference standard: Tissue biopsy/cytology or follow-up at 12 month

Primary outcome: accuracy defined as primary invasive OC versus benign or normal

Secondary outcomes: accuracy defined as primary invasive OC, secondary malignant, borderline and neoplasms of uncertain behaviour versus benign or normal

Study sample size required 150 OCs to detect 13% sensitivity improvement from 70% to 84% with 90% power, assuming positive correlation of test errors.

Sensitivity, specificity, c-index (area under Receiver operating characteristic (ROC) curve), PPV and Negative Predictive value (NPV) were reported with calibration plots.

Results 1242 postmenopausal women recruited from 23 hospitals. For primary outcome, comparing RMI 1 250, sensitivity 82.9% (95% CI: 76.7 to 88.0), specificity 87.4% (95% CI: 84.9 to 89.6), IOTA ADNeX 10% was more sensitive 96.1% (95% CI: 92.2 to 98.4) and less specific 58.5% (95% CI: 54.7 TO 62.1), p< 0.001, whilst sensitivity of ROMA at 29.9% was comparable 88.0% (95% CI: 82.5 to 92.2) with lower specificity 79.9% (95% CI: 76.9 to 82.7), p=0.0001. Analysis of secondary outcome was similar. (table 1).

Conclusion Across all analyses, IOTA ADNeX had highest sensitivity but lower specificity. ROMA at 29.9 had marginal improvement of sensitivity over RMI 250 but reduction in specificity. IOTA ADNEX at 10% should be standard of care diagnostic in OC for postmenopausal women.

Disclosures Davenport C, Rai N, Sharma P, Deeks JJ, Berhane S, Mallett S, Saha P, Champaneria R, Bayliss SE, Snell KIE, Sundar S. Menopausal status, ultrasound and biomarker tests in combination for the diagnosis of ovarian cancer in symptomatic women. Cochrane Database of Systematic Reviews 2022, Issue 7. Art. No.: CD011964. DOI: 10.1002/14651858.CD011964.pub2. Accessed 30 November 2023.