Trial · NCT07901569
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Diagnostic Performance (AUROC) of Preoperative CT/MRI Habitat Imaging for Inferior Vena Cava Wall Invasion | within 8 weeks after the surgery | The study team will measure the diagnostic performance of a habitat imaging model. The model uses preoperative contrast-enhanced CT and MRI. The target condition is inferior vena cava wall invasion. The reference standard is the structured pathology report from surgery. The primary metric is the area under the receiver operating characteristic curve (AUROC) with the 95% confidence interval. The team will also report sensitivity and specificity at a pre-specified threshold. The team will use nested cross-validation and bootstrap for internal validation. Calibration and clinical utility are secondary endpoints. |
| Secondary | Calibration of the Habitat Model | within 8 weeks after the surgery | The study team assesses calibration with intercept, slope, and Brier score. The team reports calibration plots. |
| Secondary | Clinical Utility of the Habitat Model (Decision Curve Analysis) | within 8 weeks after the surgery | The study team assesses clinical utility with decision curve analysis. The team reports net benefit across threshold probabilities. |
| Secondary | Incremental Value over Conventional Signs, Whole-tumor Radiomics, and Clinical Models | within 8 weeks after the surgery | The study team compares the habitat model with a conventional sign model, a whole-tumor radiomics model, and a clinical model. The team reports AUROC differences with 95% confidence intervals. |
| Secondary | Imaging-Pathology Agreement for Wall Invasion | within 8 weeks after the surgery | Two pathologists read each pathology report independently. The study team calculates agreement for wall invasion. The team reports Cohen kappa and the number of disagreements. A third pathologist resolves disagreements. |
| Secondary | Pathology Grading Agreement for Wall Invasion | within 8 weeks after the surgery | The study team calculates agreement for the pathology grading of wall invasion. The team reports Cohen kappa and the number of disagreements. A third pathologist resolves disagreements. |
| Secondary | Batch Effects by Scanner, Slice Thickness, and Reconstruction Kernel | within 8 weeks after the surgery | The study team compares feature variance components and AUROC across acquisition batches. The team tests the assumptions of ComBat before use. If the team uses ComBat, the team also reports unadjusted results. |
| Secondary | Spatial Transcriptomic Validation of Imaging Habitats | within 8 weeks after the surgery | The study team compares imaging habitats with spatial transcriptomic regions. The team uses available Visium data from seven tissue sections. The data come from two participants. The team maps each habitat to the transcriptomic regions in the same tissue block when possible. The team reports the correspondence descriptively. The analysis is exploratory. |
| Secondary | Habitat-associated Transcriptomic Signatures | within 8 weeks after the surgery | The study team tests habitat-associated gene expression signatures. The signatures include hypoxia, immune response, epithelial-mesenchymal transition, and tertiary lymphoid structure genes. The team compares signature scores across habitats. The analysis is exploratory. |
| Secondary | Paired Invasion versus Non-invasion Region Comparison | within 8 weeks after the surgery | One participant has paired invasion and non-invasion tissue sections. The study team compares habitat composition between the two regions. The team compares transcriptomic signatures between the two regions. The analysis is exploratory. |
| Secondary | Imaging-Omics-Pathology Concordance | within 8 weeks after the surgery | The study team compares imaging habitat results, spatial transcriptomic results, and pathology results. The team reports the concordance descriptively. The analysis is exploratory. |
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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