Deep Learning for Automated Discrimination Between Stage T1-T2 and T3 Renal Cell Carcinoma on Contrast-Enhanced CT

NCT ID: NCT07166445

Last Updated: 2025-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-01

Study Completion Date

2027-12-01

Brief Summary

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This study aims to develop and validate a contrast-enhanced CT-based deep-learning model for automatic and accurate preoperative discrimination between T1-T2 and T3 renal cell carcinoma. By quantifying the model's diagnostic performance on an independent test set-using AUC, sensitivity, specificity, positive/negative predictive values, and decision-curve analysis-we will establish a decision-support tool that can be seamlessly integrated into clinical PACS, thereby reducing staging errors, refining surgical planning, and improving patient outcomes.

Detailed Description

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Conditions

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Carcinoma, Renal Cell Diagnostic Imaging Pathology Deep Learning

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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None intervention

this study is retrospective based on the CT images, which dose include any intervention.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Histopathologically confirmed renal cell carcinoma on postoperative specimen.
2. Preoperative contrast-enhanced CT performed at our institution with slice thickness ≤ 1 mm and complete DICOM datasets.
3. Postoperative pathologic staging clearly defined as pT1a-T2b or pT3a.
4. CT image quality deemed adequate for analysis.

Exclusion Criteria

* 1\. Pathologic subtype other than RCC. 2. Images with severe artifacts.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Peking University First Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking University First Hospital, Beijing,

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zejin Ou

Role: CONTACT

159 1494 4390

Facility Contacts

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Peking University First Hospital Peking University First Hospital

Role: primary

Other Identifiers

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PUH-2025-RCC-DL-TS001

Identifier Type: -

Identifier Source: org_study_id

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