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. 2021 May 18;11(5):e047256.
doi: 10.1136/bmjopen-2020-047256.

Prospective bladder cancer infrastructure for experimental and observational research on bladder cancer: study protocol for the 'trials within cohorts' study ProBCI

Anke Richters  1   2 , Richard P Meijer  3 , Niven Mehra  4 , Joost L Boormans  5 , Antoine G van der Heijden  6 , Michiel S van der Heijden  7 , Lambertus A Kiemeney  2 , Katja K Aben  8   2
Affiliations

Prospective bladder cancer infrastructure for experimental and observational research on bladder cancer: study protocol for the 'trials within cohorts' study ProBCI

Anke Richters et al. BMJ Open. .

Abstract

Introduction: A better understanding of the molecular profile of bladder tumours, the identification of novel therapeutic targets, and introduction of new drugs and has renewed research interest in the field of bladder cancer. We describe the design and setup of a Dutch Prospective Bladder Cancer Infrastructure (ProBCI) as a means to stimulate and accelerate clinically meaningful experimental and observational research.

Methods and analysis: ProBCI entails an open cohort of patients with bladder cancer in which the trials within cohorts (TwiCs) design can be embedded. Physicians in participating hospitals prospectively recruit invasive (≥T1) patients with bladder cancer on primary diagnosis for inclusion into the study. Extensive clinical data are collected and updated every 4 months, along with patient-reported outcomes and biomaterials. Informed consent includes participation in TwiCs studies and renewed contact for future studies. Consent for participation in questionnaires and molecular analyses that may yield incidental findings is optional.

Ethics and dissemination: The Dutch ProBCI is a unique effort to construct a nation-wide cohort of patients with bladder cancer including clinical data, patient-reported outcomes and biomaterial, to facilitate observational and experimental research. Data and materials are available for other research groups on request through www.probci.nl. Ethics approval was obtained from METC Utrecht (reference: NL70207.041.19).

Trial registration number: NCT04503577.

Keywords: epidemiology; oncology; urological tumours.

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Conflict of interest statement

Competing interests: NM reports grants and personal fees from Merck Sharp & Dohme, Roche, Janssen, AstraZeneca, grants from Sanofi and Pfizer, and personal fees from Astellas Pharma, Bristol-Myers Squibb, and Bayer outside the submitted work. JLB reports personal fees from Merck Sharp & Dohme, Roche and Janssen outside the submitted work. AGvdH reports personal fees from Merck Sharp & Dohme, Roche, Janssen, Sanofi, Ipsen Farmacuetica, Astellas Pharma and MML outside the submitted work. MSvdH reports grants and personal fees from Roche, Bristol-Myers Squibb and AstraZeneca, and personal fees from Merck Sharp & Dohme, Janssen, Astellas Pharma and Seattle Genetics outside the submitted work. AR, KKA, RPM and LAK have nothing to disclose.

Figures

Figure 1
Figure 1
The cohort multiple RCT design. cmRCT, cohort multiple RCT = Twics; IC, informed consent.
See this image and copyright information in PMC

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