Trial · NCT07883551
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Discrimination of the CADx model for three-class classification (benign, borderline, malignant): macro-averaged AUROC | Preoperatively (CT scan acquired before surgery), compared with histopathology of the tumour removed at surgery | Area under the receiver operating characteristic curve (AUROC) of the SPECTRE-based CADx model on preoperative CT. Calculated per class (one-vs-rest) and macro-averaged across the three classes, with histopathology according to the 2020 WHO classification as reference standard. Reported for internal cross-validation in the development cohort and for the centre-held-out external validation cohort, with 95% confidence intervals estimated by bootstrapping. Range 0 to 1, higher values indicate better discrimination. |
| Secondary | Sensitivity, specificity and predictive values per tumour class | Preoperatively (CT scan acquired before surgery), compared with histopathology of the tumour removed at surgery | Sensitivity, specificity, positive predictive value and negative predictive value of the CADx model for each class (one-vs-rest), against histopathology. Decision thresholds are set in the development cohort and fixed before external validation. Reported with 95% confidence intervals for internal and external validation. |
| Secondary | F1-score, balanced accuracy and confusion matrix for three-class classification | Preoperatively (CT scan acquired before surgery), compared with histopathology of the tumour removed at surgery | Per-class and macro-averaged F1-score, balanced accuracy and the full three-by-three confusion matrix of predicted versus histopathological class, for internal and external validation. |
| Secondary | Calibration of predicted class probabilities | Preoperatively (CT scan acquired before surgery), compared with histopathology of the tumour removed at surgery | Agreement between predicted probabilities and observed histopathological outcomes, assessed with calibration curves and the Brier score, before and after any recalibration (for example Platt or temperature scaling). Reported for internal and external validation. |
| Secondary | Net benefit of CADx-supported triage (decision curve analysis) | Preoperatively (CT scan acquired before surgery), compared with histopathology of the tumour removed at surgery | Net benefit of using the CADx model to identify borderline or malignant tumours across a range of clinically relevant risk thresholds, compared with treat-all and treat-none strategies and with IOTA-ADNEX where available. |
| Secondary | Diagnostic performance of the CADx model compared with IOTA-ADNEX | Preoperatively (CT scan acquired before surgery), compared with histopathology of the tumour removed at surgery | Paired comparison in patients with an available or reconstructable ADNEX result. ADNEX risk categories are collapsed to benign, borderline and malignant. Compared by AUROC (DeLong test), sensitivity and specificity (McNemar's test), Brier score and agreement (kappa). |
| Secondary | Diagnostic performance of the CADx model compared with the Risk of Malignancy Index (RMI) | Preoperatively (CT scan acquired before surgery), compared with histopathology of the tumour removed at surgery | Paired comparison in patients with a calculable RMI. Because RMI is a binary score, comparison is made for benign versus borderline or malignant tumours at the threshold used in routine practice (RMI ≥200). Compared by AUROC (DeLong test) and sensitivity and specificity (McNemar's test). |
| Secondary | Diagnostic performance of the CADx model compared with the radiologist's CT report | Preoperatively (CT scan acquired before surgery), compared with histopathology of the tumour removed at surgery | Paired comparison with the classification derived from the original clinical CT report using a predefined mapping rule. Compared by sensitivity, specificity (McNemar's test) and agreement (kappa). |
| Secondary | Inter-centre generalisability of CADx performance | Preoperatively (CT scan acquired before surgery), compared with histopathology of the tumour removed at surgery | Macro-averaged AUROC, sensitivity and specificity per centre, and the difference between internal cross-validated and external validation performance, to quantify domain shift related to centre, scanner and acquisition protocol. |
| Secondary | CADx performance by histological subtype (exploratory) | Preoperatively (CT scan acquired before surgery), compared with histopathology of the tumour removed at surgery | Proportion of correctly classified tumours and class-specific sensitivity per histological subtype (2020 WHO classification), for example serous, mucinous, endometrioid, clear cell and non-epithelial tumours. |
| Secondary | CADx performance by menopausal status and tumour size | Preoperatively (CT scan acquired before surgery), compared with histopathology of the tumour removed at surgery | Macro-averaged AUROC, sensitivity and specificity in subgroups by menopausal status (pre- versus postmenopausal) and by maximum tumour diameter on imaging. |
| Secondary | CADx performance on MRI and comparison with O-RADS MRI (exploratory pilot) | Preoperatively (MRI scan acquired before surgery), compared with histopathology of the tumour removed at surgery | Within the MRI pilot cohort, AUROC, sensitivity and specificity of the CADx model on MRI against histopathology, and paired comparison with the O-RADS MRI score where available. |
| Other | Added value of blood-based biomarkers to CT-based CADx (exploratory) | Preoperatively (CT scan and blood-based biomarkers obtained before surgery), compared with histopathology of the tumour removed at surgery | Change in macro-averaged AUROC when CA-125, CA-125 glycovariants, CEA, ctDNA or proteomic data are combined with CT imaging, in the subset with linkable biomarker data. |
| Other | Added value of radiologist report content as auxiliary input (exploratory) | Preoperatively (CT scan acquired before surgery), compared with histopathology of the tumour removed at surgery | Change in macro-averaged AUROC when structured or free-text radiologist report content is added to CT imaging as model input. |
| Other | Correspondence between whole slide image features and CT-based tumour characteristics (exploratory) | Preoperatively (CT scan) and at surgery (histopathology specimen of the removed tumour) | Descriptive and quantitative association between AI-derived histopathology features on whole slide images and CT-based model representations, in a subset of tumours with digitised slides. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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