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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06381895
Other study ID # SYSKY-2023-467-01
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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