Overview
Sponsor-declared trial summary
Phase
Phase III and Phase IV (Integrated)
Status
Authorised, recruitment pending
Participants planned
152
Countries
1
Sites
1
Non-muscle invasive bladder cancer
Key facts
- Sponsor
- University Hospital Of Canary Islands
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2024-11-28
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-519890-21-00
- EudraCT number
- 2015-005151-27
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Non-muscle invasive bladder cancer
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
University Hospital Of Canary Islands
2
Total trials
Academic / Non-commercial
- Sponsor organisation
- University Hospital Of Canary Islands
- Address
- Carretera De La Cuesta Taco S/n, Cuesta La Cuesta La
- City
- San Cristobal De La Laguna
- Postcode
- 38320
- Country
- Spain
Scientific contact point
- Organisation
- University Hospital Of Canary Islands
- Contact name
- Ana Plata Bello
Public contact point
- Organisation
- University Hospital Of Canary Islands
- Contact name
- Ana Plata Bello
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 152 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
University Hospital Of Canary Islands
Urology, Carretera De La Cuesta Taco S/n, Cuesta La, San Cristobal De La Laguna
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-26 | Spain | Acceptable 2024-11-28
|
2024-11-28 |