Clinical trial NCT04503577: Prospective Bladder Cancer Infrastructure (ProBCI)
Official title: Prospective Bladder Cancer Infrastructure: an Infrastructure for Observational and Interventional Bladder Cancer Research (ProBCI)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bladder Cancer
Keywords: Bladder cancer
Prospective cohort
Lead sponsor: Prospective Bladder Cancer Infrastructure Foundation
Sponsor class: OTHER
First posted: 2020-08-07
Enrollment: 3600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Bladder cancer patients with high-risk non-muscle-invasive bladder cancer (T1, Tis or Ta+cis), muscle-invasvie bladder cancer (T2-4, any N, M0/X), and metastatic bladder cancer (any T, any N, M1a/b)

Brief summary: Prospective nation-wide cohort of high-risk non-muscle-invasive, muscle-invasive and metastatic bladder cancer in the Netherlands


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.

Primary outcomes:
measure: Overall survival
timeFrame: 10 years
Secondary outcomes:
measure: Progression-free survival
timeFrame: 10 yeas
measure: Recurrence-free survival
timeFrame: 10 yeas
measure: Health-related quality of life
timeFrame: 2 years
measure: Cancer-specific health-related quality of life
timeFrame: 2 years
Other outcomes:
Locations:
city: 's-Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Hospital
city: Almelo
country: Netherlands
facility: ZGT
city: Amersfoort
country: Netherlands
facility: Meander Medical Center
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, location VUMC
city: Arnhem
country: Netherlands
facility: Rijnstate
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Hospital
city: Ede
country: Netherlands
facility: Ziekenhuis Gelderse Vallei
city: Emmen
country: Netherlands
facility: Treant Hospital
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Hoofddorp
country: Netherlands
facility: Spaarne Gasthuis
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
city: Leiderdorp
country: Netherlands
facility: Alrijne Ziekenhuis
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: Nijmegen
country: Netherlands
facility: Canisius Wilhelmina Ziekenhuis
city: Nijmegen
country: Netherlands
facility: Radboud univerisity Medical Center
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
city: Sittard
country: Netherlands
facility: Zuyderland
city: Tilburg
country: Netherlands
facility: Elisabeth-TweeSteden Ziekenhuis
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
city: Venlo
country: Netherlands
facility: VieCuri
city: Winterswijk
country: Netherlands
facility: SKB Winterswijk
city: Zwolle
country: Netherlands
facility: Isala
Study officials:
References:
citation: 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.
citation: 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.