Recruiting NCT04503577
Prospective Bladder Cancer Infrastructure (ProBCI)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Bladder Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective Bladder Cancer Infrastructure: an Infrastructure for Observational and Interventional Bladder Cancer Research (ProBCI)
Overview
Prospective nation-wide cohort of high-risk non-muscle-invasive, muscle-invasive and metastatic bladder cancer in the Netherlands
Primary outcome measures
- Overall survival [Time frame: 10 years]
Secondary outcome measures (4)
- Progression-free survival [Time frame: 10 yeas]
- Recurrence-free survival [Time frame: 10 yeas]
- Health-related quality of life [Time frame: 2 years]
- Cancer-specific health-related quality of life [Time frame: 2 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Netherlands · 23 centers
- Jeroen Bosch Hospital — 's-Hertogenbosch
- ZGT — Almelo
- Meander Medical Center — Amersfoort
- Amsterdam UMC, location VUMC — Amsterdam
- Rijnstate — Arnhem
- Amphia Ziekenhuis — Breda
- Albert Schweitzer Hospital — Dordrecht
- Ziekenhuis Gelderse Vallei — Ede
- … and 15 more centers
Publications
- Richters A, Meijer RP, Mehra N, Boormans JL, van der Heijden AG, van der Heijden MS, Kiemeney LA, Aben KK. Prospective bladder cancer infrastructure for experimental and observational research on bladder cancer: study protocol for the 'trials within cohorts' study ProBCI. BMJ Open. 2021 May 18;11(5):e047256. doi: 10.1136/bmjopen-2020-047256. PMID 34006553
- Richters A, Mehra N, Meijer RP, Boormans JL, van der Heijden AG, Smilde TJ, van der Heijden MS, Kiemeney LA, Aben KK. Utilization of systemic treatment for metastatic bladder cancer in everyday practice: Results of a nation-wide population-based cohort study. Cancer Treat Res Commun. 2020;25:100266. doi: 10.1016/j.ctarc.2020.100266. Epub 2020 Dec 8. PMID 33316557
Identifiers
NCT: NCT04503577 · ProBCI