- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06167863
Retrospective Analysis of the Correlation Between Imaging Features and Pathology, Prognosis in Renal Tumors
December 11, 2023 updated by: Zhen Li
Retrospective Analysis of the Correlation Between CT/MRI Imaging Features and Pathology, Prognosis in Patients With Renal Tumors
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Renal cell carcinoma (RCC) accounts for 80-90% of malignant tumors in the kidney and has the highest mortality rate among genitourinary tumors.
Imaging examinations play an important role in the diagnosis, preoperative assessment, selection of surgical methods, and evaluation of therapeutic efficacy in RCC.
However, traditional imaging primarily reflects the morphological and functional changes of the tumor and cannot reflect the internal heterogeneity.
In the current era of precision medicine, radiomics can provide internal features of lesions that cannot be observed by the naked eye, enabling precise diagnosis, prognosis prediction, efficacy evaluation, and personalized treatment planning for tumors.
Renal cell carcinoma is highly elusive, with over 30% of patients already experiencing metastasis at the time of initial diagnosis, and it is insensitive to radiotherapy and chemotherapy.
Early diagnosis and differential diagnosis of renal tumors are important prognostic factors that affect patient survival and treatment.
Given the different treatment approaches, preoperative differentiation of lesion nature holds significant clinical significance.
However, there is some overlap in the morphological and pathological features between benign and malignant lesions of the kidney, making it difficult to differentially diagnose such tumors using existing imaging techniques alone.
Therefore, the accurate diagnosis of renal cell carcinoma, especially for small renal tumors (≤4cm), remains a significant challenge.
In recent years, the relationship between body composition, such as obesity, and renal tumors has received increasing attention.
Previous studies have shown a close association between obesity and kidney cancer.
Common indicators such as body weight, BMI, and waist circumference fail to effectively reflect body composition, including various fat and muscle distributions and relative amounts.
Different body compositions have different physiological functions and varying impacts on tumors.
Further specific research on the true role of various body compositions, including adipose tissue, in tumor pathology would aid in clinical diagnosis and subsequent treatment planning.
Study Type
Observational
Enrollment (Actual)
1000
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
-
-
Hubei
-
Wuhan, Hubei, China, 430030
- Zhen Li
-
-
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 diagnosed with renal tumors
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
WHO ISUP grading high
high-grade refer to Grades 3 and 4 tumours with an unfavourable prognosis
|
extracted image features from CT or MRI
|
WHO ISUP grading low
low-grade refer to Grades 1 and 2 tumours with a promising prognosis
|
extracted image features from CT or MRI
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
WHO/ISUP grade pathologically
Time Frame: 1 month
|
The WHO ISUP grade of the tumor indicated in the post-operative surgical pathology report
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pathological T stage
Time Frame: 1 month
|
pathological T stage according to the eighth TNM system.
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Li Dr, Tongji Hospital
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 31, 2023
Primary Completion (Actual)
October 31, 2023
Study Completion (Actual)
October 31, 2023
Study Registration Dates
First Submitted
November 30, 2023
First Submitted That Met QC Criteria
December 11, 2023
First Posted (Estimated)
December 13, 2023
Study Record Updates
Last Update Posted (Estimated)
December 13, 2023
Last Update Submitted That Met QC Criteria
December 11, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TJ-IRB20230893
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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