Prospective Bladder Cancer Infrastructure - An infrastructure for observational and interventional bladder cancer research

Prospective Bladder Cancer Infrastructure - An infrastructure for observational and interventional bladder cancer research - ProBCI

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON54621

Enrollment

3500

Registered

2020-02-25

Start date

2020-10-04

Completion date

Unknown

Last updated

2025-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bladder cancer

Interventions

Not applicable.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Histologically proven bladder cancer (high-risk non-muscle-invasive / muscle-invasive / metastatic) Written informed consent

Exclusion criteria

Exclusion criteria: Bladder cancer stage Ta Inable to read and understand informed consent procedure No inhabitant of the Netherlands

Design outcomes

Primary

Measure	Time frame
The ProBCI infrastructure aims to facilitate research on bladder cancer patient in the Netherlands. Main study endpoints of interest for studies conducted within ProBCI may include: • Efficacy/effectiveness of novel therapies (response, relapse-free survival, progression-free survival, overall survival), in the general population and in specific subgroups; • HRQoL questionnaires at diagnosis, after 6 months, and after 12 and 24 months. Additional HRQoL questionnaires may be provided for specific studies performed within the ProBCI infrastructure. • Association between patient- and tumor characteristics, genetic alterations and immune landscape, and outcomes of various current and novel therapies; • Changes in genetic, molecular and immunological landscape during disease course; More specific endpoints will be formulated in the study protocols of future studies conducted within ProBCI.	—

Measure

Time frame

The ProBCI infrastructure aims to facilitate research on bladder cancer patient in the Netherlands. Main study endpoints of interest for studies conducted within ProBCI may include: • Efficacy/effectiveness of novel therapies (response, relapse-free survival, progression-free survival, overall survival), in the general population and in specific subgroups; • HRQoL questionnaires at diagnosis, after 6 months, and after 12 and 24 months. Additional HRQoL questionnaires may be provided for specific studies performed within the ProBCI infrastructure. • Association between patient- and tumor characteristics, genetic alterations and immune landscape, and outcomes of various current and novel therapies; • Changes in genetic, molecular and immunological landscape during disease course; More specific endpoints will be formulated in the study protocols of future studies conducted within ProBCI.

—

Secondary

Measure	Time frame
N.a.	—

Countries

Netherlands

Contacts

Public ContactA. Richters

Stichting Prospectieve Blaaskanker Infrastructuur

a.richters@iknl.nl0623237842

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)