NCT06167863

Brief Summary

Renal cell carcinoma (RCC) is the most common malignant tumor in the kidney with a high mortality rate. Traditional imaging techniques are limited in capturing the internal heterogeneity of the tumor. Radiomics provides internal features of lesions for precise diagnosis, prognosis prediction, and personalized treatment planning. Early and accurate diagnosis of renal tumors is crucial, but it's challenging due to morphological and pathological overlap between benign and malignant lesions. The accurate diagnosis of RCC, especially for small tumors, remains a significant challenge. Recent studies have shown a relationship between body composition, obesity, and renal tumors. Common indicators like body weight and BMI fail to reflect body composition accurately. Research on the role of body composition, including adipose tissue, in tumor pathology could improve clinical diagnosis and treatment planning.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 31, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 30, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 13, 2023

Completed
Last Updated

December 13, 2023

Status Verified

December 1, 2023

Enrollment Period

2 months

First QC Date

November 30, 2023

Last Update Submit

December 11, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • WHO/ISUP grade pathologically

    The WHO ISUP grade of the tumor indicated in the post-operative surgical pathology report

    1 month

Secondary Outcomes (1)

  • pathological T stage

    1 month

Study Arms (2)

WHO ISUP grading high

high-grade refer to Grades 3 and 4 tumours with an unfavourable prognosis

Diagnostic Test: radiomics

WHO ISUP grading low

low-grade refer to Grades 1 and 2 tumours with a promising prognosis

Diagnostic Test: radiomics

Interventions

radiomicsDIAGNOSTIC_TEST

extracted image features from CT or MRI

WHO ISUP grading highWHO ISUP grading low

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients diagnosed with renal tumors

You may qualify if:

  • Our hospital admits patients with renal tumors in the urology department. The diagnosis is confirmed through surgical pathology, and the patients' imaging data is obtained through contrast-enhanced Computed Tomography or Magnetic Resonance examination in the radiology department.

You may not qualify if:

  • Patients who have undergone puncture, microwave, interventional therapies before the examination, or who have received chemotherapy or radiotherapy;
  • Patients with poor respiratory coordination, resulting in significant image artifacts;
  • Lesions are cystic, without discernible regions of interest, or with multiple regions of necrosis within the lesion;
  • Lesions are too small, with a diameter of less than 1cm;
  • Thin-slice imaging is not available in the CT scan.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhen Li

Wuhan, Hubei, 430030, China

Location

Related Publications (1)

  • Li S, Zhou Z, Gao M, Liao Z, He K, Qu W, Li J, Kamel IR, Chu Q, Zhang Q, Li Z. Incremental value of automatically segmented perirenal adipose tissue for pathological grading of clear cell renal cell carcinoma: a multicenter cohort study. Int J Surg. 2024 Jul 1;110(7):4221-4230. doi: 10.1097/JS9.0000000000001358.

MeSH Terms

Interventions

Radiomics

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Li Dr

    Tongji Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

November 30, 2023

First Posted

December 13, 2023

Study Start

August 31, 2023

Primary Completion

October 31, 2023

Study Completion

October 31, 2023

Last Updated

December 13, 2023

Record last verified: 2023-12

Locations