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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06381895
• Other study ID #: SYSKY-2023-467-01
• Status: Completed
• Start date: May 30, 2023
• Est. completion date: February 20, 2024

Study information

• Verified date: April 2024
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: February 20, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bladder Cancer
• Immunotherapy
• Radiomics
• Urinary Bladder Neoplasms

Locations

Country	Name	City	State
China	Sun Yat-sen Memorial Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumour-infiltrating lymphocytes (TIL)	TILs were evaluated using paraffin-embedded tumour tissue samples stained with H&E according to established protocols.	1 year
Secondary	overall survival	We obtain this data through telephone follow-up and evaluate it according to the date of surgery	1 year
Secondary	cancer-specific survival	We obtain this data through telephone follow-up and evaluate it according to the date of surgery	1 year