NCT07117786

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,437

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2023

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 12, 2025

Completed
Last Updated

August 12, 2025

Status Verified

August 1, 2025

Enrollment Period

7.3 years

First QC Date

August 5, 2025

Last Update Submit

August 5, 2025

Conditions

Keywords

Renal Function DeclineRenal Cell CarcinomaComputed Tomography

Outcome Measures

Primary Outcomes (1)

  • early postoperative renal function decline

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

    within 3 to 24 months postoperatively

Interventions

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.

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population was drawn from the following institutions: the First Affiliated Hospital of Fujian Medical University, the Second Affiliated Hospital of Fujian Medical University, the First Affiliated Hospital of Xiamen University, the Second People's Hospital affiliated with Fujian University of Traditional Chinese Medicine, the First Affiliated Hospital of Chongqing Medical University, and Quanzhou First Hospital affiliated with Fujian Medical University

You may qualify if:

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

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2025

First Posted

August 12, 2025

Study Start

January 1, 2016

Primary Completion

May 6, 2023

Study Completion

June 1, 2023

Last Updated

August 12, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share