A Research Protocol for Evaluating the Efficacy of Perfused Chemotherapeutic Agents for Bl
The investigators are here to invite participants to participate in a medical research project, and this informed consent form provides participants with information to decide whether or not to participate in this study. Please read the following carefully and discuss any questions and terms that are not clear with the
| Condition(s) | Bladder Cancer |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | The investigators are here to invite participants to participate in a medical research project, and this informed consent form provides participants with information to decide whether or not to participate in this study. Please read the following carefully and discuss any questions and terms that are not clear with the study doctor. The participants' participation in this study is completely voluntary and the project has been reviewed by the Research Ethics Committee of Qilu Hospital, Shandong University. |
| Who can participate | Inclusion criteria: 1. Age 18-80 years old, gender is not limited; 2. Patients with intermediate-risk and high-risk non-muscle invasive bladder cancer (NMIBC) requiring bladder perfusion therapy; 3. No prior bladder perfusion therapy (except immediate postoperative perfusion); 4. ECOG status score of 0-2; 5. Be able to comply with the trial protocol, have good compliance, cooperate in observing adverse events and efficacy and cooperate in follow-up, as judged by the investigator; 6. Voluntarily participate in this clinical trial, understand the study procedures and have signed the informed consent to participate in this study; Exclusion criteria: 1. bladder perforation during TURBT, postoperative gross haematuria, symptomatic severe chemical cystitis, and urinary tract infection; 2. Immuno |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Lead sponsor | Qilu Hospital of Shandong University |
| Locations | Binzhou, Shandong, China; Dezhou, Shandong, China; Jinan, Shandong, China; Jinan, Shandong, China; Jinan, Shandong, China; Jinan, Shandong, China (+11 more sites) |
| Start date | 2024-10-01 |
| NCT ID | NCT06662071 |
| Official listing | https://clinicaltrials.gov/study/NCT06662071 |