The Efficacy of Radiomics to Predict Tumor Microenvironment Markers and Comprehensive Therapy for Bladder Cancer

Completed

• Conditions: Immunotherapy; Bladder Cancer; Radiomics

• Registration Number: NCT06381895
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief Summary

The aim of this study was to develop an radiomic model based on CT images to evaluate markers of the bladder cancer microenvironment, such as TSR,TIL, and IP. Secondly, the association of the radiomic model with clinical outcomes and immunotherapy response was investigated.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-30
• Primary Completion: 2024-02-01
• Study Completion: 2024-02-20
• Status Verified: 2024-04
• Study First Submitted: 2024-04-15
• Study First Submitted QC: 2024-04-19
• Last Update Submitted: 2024-04-19
• Study First Posted: 2024-04-24
• Last Update Posted: 2024-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

1. At least 18 years of age;
2. Performing TURB-t or RC during 2010-2022;
3. The primary lesion was located in the bladder, and the pathological diagnosis was urothelial carcinoma;
4. Complete clinical information, pathological data, preoperative pelvic enhanced CT and follow-up records;

Exclusion Criteria

1. Patients with distant metastasis;
2. Combined with other malignant tumors or malignant tumor treatment history
3. Malignant tumors of upper urinary tract;
4. Clinical information, pathological data, preoperative pelvic enhanced CT and follow-up records were missing;
5. Other situations in which the researcher considers it inappropriate to participate in this study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tumour-infiltrating lymphocytes (TIL)	1 year	TILs were evaluated using paraffin-embedded tumour tissue samples stained with H\&E according to established protocols.

Secondary Outcome Measures

Name	Time	Method
overall survival	1 year	We obtain this data through telephone follow-up and evaluate it according to the date of surgery
cancer-specific survival	1 year	We obtain this data through telephone follow-up and evaluate it according to the date of surgery

Trial Locations

Locations (1)

Sun Yat-sen Memorial Hospital; 🇨🇳 Guangzhou, Guangdong, China