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

NCT06381895 | Completed

• 1 other identifier: SYSKY-2023-467-01
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer; Radiomics; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Tumour-infiltrating lymphocytes (TIL)

  TILs were evaluated using paraffin-embedded tumour tissue samples stained with H\&E according to established protocols.

  1 year

Secondary Outcomes (2)

• overall survival

  1 year

• cancer-specific survival

  1 year

Study Arms (3)

1

Sun Yat-sen Memorial Hospital cohort

2

Third Affiliated Hospital of Sun Yat-sen University cohort

3

Sun Yat-sen University Cancer Center cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with histologically confirmed primary bladder cancers

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, China

Location

Related Publications (1)

• Chen K, Li X, Liu L, Wang B, Liang W, Chen J, Gao M, Huang X, Liu B, Sun X, Yang T, Zhao X, He W, Luo Y, Huang J, Lin T, Zhong W. Correlation of noninvasive imaging of tumour-infiltrating lymphocytes with survival and BCG immunotherapy response in patients with bladder cancer: a multicentre cohort study. Int J Surg. 2025 Jan 1;111(1):920-931. doi: 10.1097/JS9.0000000000001999.

  PMID: 40053821 DERIVED

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Liushan Ou

  Medical Ethics Committee, Sun Yat-sen Memorial Hospital, Sun Yat-sen University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 24, 2024
• Study Start: May 30, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 20, 2024
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)