Bladder Cancer Clinical Trial
— ProBCIOfficial title:
Prospective Bladder Cancer Infrastructure: an Infrastructure for Observational and Interventional Bladder Cancer Research (ProBCI)
| NCT number | NCT04503577 |
| Other study ID # | ProBCI |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | October 4, 2020 |
| Est. completion date | December 31, 2041 |
Prospective nation-wide cohort of high-risk non-muscle-invasive, muscle-invasive and metastatic bladder cancer in the Netherlands
| Status | Recruiting |
| Enrollment | 3600 |
| Est. completion date | December 31, 2041 |
| Est. primary completion date | December 31, 2040 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Bladder cancer - Any stage except Ta - 18 years or older - Written informed consent Exclusion Criteria: - No exclusion criteria Note: participation in ProBCI does not exclude the patient from participation in other studies. |
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | Jeroen Bosch Hospital | 's-Hertogenbosch | |
| Netherlands | ZGT | Almelo | |
| Netherlands | Meander Medical Center | Amersfoort | |
| Netherlands | Amsterdam UMC, location VUMC | Amsterdam | |
| Netherlands | Rijnstate | Arnhem | |
| Netherlands | Amphia Ziekenhuis | Breda | |
| Netherlands | Albert Schweitzer Hospital | Dordrecht | |
| Netherlands | Ziekenhuis Gelderse Vallei | Ede | |
| Netherlands | Treant Hospital | Emmen | |
| Netherlands | University Medical Center Groningen | Groningen | |
| Netherlands | Spaarne Gasthuis | Hoofddorp | |
| Netherlands | Medisch Centrum Leeuwarden | Leeuwarden | |
| Netherlands | Alrijne Ziekenhuis | Leiderdorp | |
| Netherlands | Maastricht University Medical Center | Maastricht | |
| Netherlands | Canisius Wilhelmina Ziekenhuis | Nijmegen | |
| Netherlands | Radboud univerisity Medical Center | Nijmegen | |
| Netherlands | Erasmus Medical Center | Rotterdam | |
| Netherlands | Zuyderland | Sittard | |
| Netherlands | Elisabeth-TweeSteden Ziekenhuis | Tilburg | |
| Netherlands | University Medical Center Utrecht | Utrecht | |
| Netherlands | VieCuri | Venlo | |
| Netherlands | SKB Winterswijk | Winterswijk | |
| Netherlands | Isala | Zwolle |
| Lead Sponsor | Collaborator |
|---|---|
| Prospective Bladder Cancer Infrastructure Foundation |
Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall survival | Alive/death/emigrated | 10 years | |
| Secondary | Progression-free survival | Progression/no progression | 10 yeas | |
| Secondary | Recurrence-free survival | Recurrence/no recurrence | 10 yeas | |
| Secondary | Health-related quality of life | EQ-5D (EuroQol-Five Dimensions) | 2 years | |
| Secondary | Cancer-specific health-related quality of life | QLQ-C30 (Quality of Life Questionnaire-Cancer) | 2 years |
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