Predicting HIF-2α Levels in Clear Cell Kidney Cancer Using Machine Learning

Development of a Machine Learning-Based Nomogram for Predicting HIF-2α Expression Levels in Clear Cell Renal Cell Carcinoma

This project aims to conduct a multicenter retrospective study to collect clinical, CT imaging, and pathological data from patients. A comprehensive data management system will be established, and radiomic features will be extracted to integrate and analyze multicenter data. We will develop a predictive model based on CT radiomic features and perform both internal and external cohort validation. The model will predict HIF-2α expression levels and clinically relevant prognostic factors in ccRCC, enabling precise identification of patient populations responsive to the HIF-2α antagonist Belzutifan, thereby facilitating personalized treatment decisions, minimizing unnecessary therapeutic risks, and ultimately improving patient quality of life and clinical outcomes.

Study Overview

Status

Active, not recruiting

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Fujian
      • Fuzhou, Fujian, China, 350005
        • first hospital affiliated of Fujian medical university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with histologically confirmed renal cell carcinoma

Description

Inclusion Criteria:

  • Pathologically confirmed clear cell renal cell carcinoma (ccRCC)
  • Availability of comprehensive clinical, pathological, and follow-up information
  • Access to preoperative non-contrast and contrast-enhanced CT images through the PACS database
  • Adequately preserved pathological slides for subsequent immunohistochemical (IHC) or tissue microarray analysis
  • Minimum of one post-treatment follow-up with documented treatment response or efficacy evaluation

Exclusion Criteria:

  • Patients considered ineligible for treatment owing to severe comorbid conditions or inability to undergo any therapeutic intervention
  • Patients with concurrent malignancies, including prior treatment for other cancers or presence of untreated active malignancies
  • Patients with inadequate CT image quality or missing imaging data
  • Patients with missing or incomplete clinical, pathological, or follow-up information

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HIF-2α Expression Levels in Clear Cell Renal Cell Carcinoma
Time Frame: 1 week
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

December 31, 2025

First Submitted That Met QC Criteria

December 31, 2025

First Posted (Estimated)

January 12, 2026

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

December 31, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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