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Completed

NCT Number: NCT07117786

Computed Tomography Radiomics-Derived Nomogram for Predicting Early Renal Function Decline After Partial Nephrectomy in Renal Cell Carcinoma: A Multicenter Development/Validation Study

The goal of this observational study is to explore the relationship between CT-based radiomics and postoperative renal function changes in patients with localized renal cell carcinoma (RCC) undergoing partial nephrectomy (PN). The main question it aims to answer is: Can a radiomics-clinical nomogram integrating CT-based radiomics features with preoperative and intraoperative clinical variables accurately predict early postoperative renal function decline in patients with localized RCC undergoing PN? Participants already undergoing renal CT examination and scheduled for postoperative renal function testing as part of the routine perioperative care will receive renal function assessment after completing surgical treatment for RCC.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • (1) postoperative pathological confirmation of RCC; (2) preoperative contrast-enhanced CT of the kidney or abdomen.

Exclusion criteria

  • (1) absence of corticomedullary, nephrographic, or excretory phase CT sequences; (2) poor-quality CT images unsuitable for analysis; (3) incomplete clinicopathologic data; (4) missing renal function data during postoperative follow-up; (5) unavailable renal function assessment within two weeks before surgery.

Treatment and study plan

CT Contrast

Other

Participants will undergo a CT-based radiomics assessment as part of the intervention. This approach involves the extraction of high-dimensional quantitative imaging features from preoperative contrast-enhanced CT scans, which are then analyzed using machine learning algorithms to identify patterns predictive of early postoperative renal function decline. Unlike conventional radiologic evaluations that rely on visual inspection and basic metrics (e.g., tumor size or enhancement), this radiomics-based intervention captures subtle heterogeneity within renal tumors and surrounding parenchyma. The integration of these features with clinical variables distinguishes this study from other imaging or predictive model studies, enabling the development of a personalized nomogram for patients with localized RCC undergoing partial nephrectomy.

Computed tomography

Other

Participants will undergo a CT-based radiomics assessment as part of the intervention. This approach involves the extraction of high-dimensional quantitative imaging features from preoperative contrast-enhanced CT scans, which are then analyzed using machine learning algorithms to identify patterns predictive of early postoperative renal function decline. Unlike conventional radiologic evaluations that rely on visual inspection and basic metrics (e.g., tumor size or enhancement), this radiomics-based intervention captures subtle heterogeneity within renal tumors and surrounding parenchyma. The integration of these features with clinical variables distinguishes this study from other imaging or predictive model studies, enabling the development of a personalized nomogram for patients with localized RCC undergoing partial nephrectomy.

Primary outcomes

  1. early postoperative renal function decline

    Time frame: within 3 to 24 months postoperatively

    early Renal function decline after PN was defined as a ≥25% reduction in eGFR from the preoperative baseline within 3 to 24 months postoperatively

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Fujian Medical University

Other

Registry information

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Aug 12, 2025
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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