JRCT ID: jRCT1050240231
Registered date:06/01/2025
Multi-institutional observational study on the treatment of unresectable urothelial carcinoma in the era of combined immunotherapy
Basic Information
| Recruitment status | Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | Urothelial carcinoma |
| Date of first enrollment | 06/01/2025 |
| Target sample size | 1200 |
| Countries of recruitment | |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | Overall survival for 1st line treatment |
|---|---|
| Secondary Outcome | Selection of 1st line and Sequential Treatment Regimens Patient Background by 1st line and Sequential Treatment Regimen Progression-free survival for 1st line treatment Safety, including treatment-related adverse events |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | Not applicable |
| Gender | |
| Include criteria | Patients with unresectable or metastatic urothelial carcinoma who may be eligible for systemic drug therapy as first line treatment. A history of perioperative chemotherapy and adjuvant therapy is acceptable. Patients who have elected to receive no treatment due to their general condition or social background are also acceptable. |
| Exclude criteria | Not specified. |
Related Information
| Primary Sponsor | Kobayashi Takashi |
|---|---|
| Secondary Sponsor | Astellas Pharma Inc. |
| Source(s) of Monetary Support | |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Yuki Kita |
| Address | Syougoinkawaharacho54 Kyoto Japan 6068507 |
| Telephone | +81-9094031731 |
| kitayuki@kuhp.kyoto-u.ac.jp | |
| Affiliation | Kyoto University Hospital |
| Scientific contact | |
| Name | Takashi Kobayashi |
| Address | Syougoinkawaharacho54 Kyoto Japan 606-8507 |
| Telephone | +81-757513337 |
| selecao@kuhp.kyoto-u.ac.jp | |
| Affiliation | Kyoto University Hospital |