Non-muscle-invasive bladder cancer
Conditions
Interventions
Observation Group (>=cutoff group):None
Observation Group (<cutoff group):None
Sponsors
Cancer Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18–80 years; 2. Pathologically confirmed non-muscle invasive bladder cancer by transurethral resection of bladder tumor, with no evidence of lymph node metastasis or distant metastasis on imaging; 3. Classified as high-risk group or above according to risk stratification; 4. No immunodeficiency-related diseases; 5. Willing to participate in the study and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Those who meet any of the following criteria: (1) Have immunodeficiency or impairment (e.g., AIDS patients), are using immunosuppressive drugs or receiving radiotherapy, or have conditions that may cause systemic BCG disease reactions; (2) Are allergic to any excipients of BCG vaccine; (3) Have fever or acute infectious diseases, including active tuberculosis, or are receiving anti-tuberculosis treatment; (4) Have severe chronic cardiovascular or cerebrovascular diseases, or chronic kidney disease; (5) Receive vaccinations during the treatment period; 2. Those with other genitourinary system tumors or other organ tumors; 3. Those with muscle-invasive bladder urothelial carcinoma (stage T2 or higher); 4. Those who have received chemotherapy, radiotherapy, or immunotherapy within the past 4 weeks (except for immediate postoperative intravesical chemotherapy); 5. Pregnant or breastfeeding women, women of childbearing age who are not using effective contraceptive measures, or those planning to become pregnant during the trial period (including pregnancy of a male subject's partner); 6. Those with known or suspected intraoperative bladder perforation; 7. Those with gross hematuria before enrollment, where surgical wound non-healing or urinary tract mucosal injury is suspected; 8. Those with cystitis, or those who have previously received other intravesical drug therapies and have severe bladder irritation symptoms that may interfere with the evaluation of this study; 9. Those who have participated in other drug clinical trials within 3 months before enrollment; 10. Those known to have opioid or alcohol dependence; 11. Any conditions that the investigator believes may increase the subject's risk or interfere with the execution of the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Routine Blood Test;Routine urine test;Fibrinogen;D-dimer;C-reactive protein;Immunoglobulin A;Immunoglobulin G;Immunoglobulin M;Complement C3;Complement C4;Lymphocyte subset assay; | — |
Countries
China
Contacts
Public ContactShou Jianzhong
Cancer Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed