NCT07060248

Brief Summary

To evaluate the efficacy of CT-based radiomics in differentiating benign from malignant renal tumors, predicting nuclear grading of renal cell carcinoma, and assessing T-stage of renal tumors, thereby exploring its clinical application value.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started Jan 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress56%
Jan 2025Jun 2027

Study Start

First participant enrolled

January 1, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 11, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

July 11, 2025

Status Verified

July 1, 2025

Enrollment Period

2.5 years

First QC Date

June 23, 2025

Last Update Submit

July 10, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • CT-based radiomics analysis for benign and malignant tumor differentiation

    Histopathological diagnosis served as the gold standard, with tumors classified into: (1) Benign renal tumors: Including lipid-poor angiomyolipoma and renal oncocytoma; (2) Malignant renal tumors: Comprising clear cell renal cell carcinoma, papillary renal cell carcinoma, and chromophobe renal cell carcinoma

    within 1 month

  • CT-based radiomics analysis for nuclear grading of clear cell renal cell carcinoma (ccRCC)

    Histopathological diagnosis served as the gold standard, with tumors classified into: (1) low grade ccRCC: Including WHO/ISUP grade 1-2 ccRCC; (2) high grade ccRCC: Including WHO/ISUP grade 3-4 ccRCC

    within 1 month

  • CT-based radiomics analysis of T-stage classification of renal cell carcinoma (RCC)

    Histopathological diagnosis served as the gold standard, with tumors classified into: (1) low T-stage RCC: Including T1-2 RCC; (2) high T-stage RCC: including T3-4 RCC

    within 1 month

Study Arms (1)

RCC group, non-RCC group; WHO/ISUP low-grade ccRCC, high-grade ccRCC; T3 tumor, T1-T2 tumor

Eligibility Criteria

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

Patients with renal mass

You may qualify if:

  • Pathologically confirmed renal tumors (including clear cell renal cell carcinoma, papillary renal cell carcinoma, chromophobe renal cell carcinoma, angiomyolipoma, and oncocytoma).
  • Contrast-enhanced CT scan was performed preoperatively.

You may not qualify if:

  • Pure cystic clear cell renal cell carcinoma
  • Poor-quality CT images

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Xiangya Hospital

Changsha, Hunan, China

Location

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

June 23, 2025

First Posted

July 11, 2025

Study Start

January 1, 2025

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

July 11, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

The original data were not publicly available and could only be shared with the permission of the local ethics committee.

Locations