Prospective Bladder Cancer Infrastructure (ProBCI) (ProBCI)

November 15, 2023 updated by: Prospective Bladder Cancer Infrastructure Foundation

Prospective Bladder Cancer Infrastructure: an Infrastructure for Observational and Interventional Bladder Cancer Research (ProBCI)

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

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

3600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
      • 's-Hertogenbosch, Netherlands
        • Recruiting
        • Jeroen Bosch Hospital
      • Almelo, Netherlands
        • Recruiting
        • ZGT
      • Amersfoort, Netherlands
        • Recruiting
        • Meander Medical Center
      • Amsterdam, Netherlands
        • Recruiting
        • Amsterdam UMC, location VUmc
      • Arnhem, Netherlands
        • Recruiting
        • Rijnstate
      • Breda, Netherlands
        • Recruiting
        • Amphia Ziekenhuis
      • Dordrecht, Netherlands
        • Recruiting
        • Albert Schweitzer Hospital
      • Ede, Netherlands
        • Recruiting
        • Ziekenhuis Gelderse Vallei
      • Emmen, Netherlands
        • Recruiting
        • Treant Hospital
      • Groningen, Netherlands
        • Recruiting
        • University Medical Center Groningen
      • Hoofddorp, Netherlands
        • Not yet recruiting
        • Spaarne Gasthuis
      • Leeuwarden, Netherlands
        • Recruiting
        • Medisch Centrum Leeuwarden
      • Leiderdorp, Netherlands
        • Recruiting
        • Alrijne Ziekenhuis
      • Maastricht, Netherlands
        • Recruiting
        • Maastricht University Medical Center
      • Nijmegen, Netherlands
        • Recruiting
        • Canisius Wilhelmina Ziekenhuis
      • Nijmegen, Netherlands
        • Recruiting
        • Radboud univerisity Medical Center
      • Rotterdam, Netherlands
        • Recruiting
        • Erasmus Medical Center
      • Sittard, Netherlands
        • Recruiting
        • Zuyderland
      • Tilburg, Netherlands
        • Recruiting
        • Elisabeth-TweeSteden Ziekenhuis
      • Utrecht, Netherlands
        • Recruiting
        • University Medical Center Utrecht
      • Venlo, Netherlands
        • Recruiting
        • VieCuri
      • Winterswijk, Netherlands
        • Recruiting
        • SKB Winterswijk
      • Zwolle, Netherlands
        • Recruiting
        • Isala

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

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)

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Bladder cancer patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 10 years
Alive/death/emigrated
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: 10 yeas
Progression/no progression
10 yeas
Recurrence-free survival
Time Frame: 10 yeas
Recurrence/no recurrence
10 yeas
Health-related quality of life
Time Frame: 2 years
EQ-5D (EuroQol-Five Dimensions)
2 years
Cancer-specific health-related quality of life
Time Frame: 2 years
QLQ-C30 (Quality of Life Questionnaire-Cancer)
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prospective Bladder Cancer Infrastructure Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2020

Primary Completion (Estimated)

December 31, 2040

Study Completion (Estimated)

December 31, 2041

Study Registration Dates

First Submitted

August 4, 2020

First Submitted That Met QC Criteria

August 4, 2020

First Posted (Actual)

August 7, 2020

Study Record Updates

Last Update Posted (Estimated)

November 17, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ProBCI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual patient data are available upon request to other research groups (please see www.probci.nl for procedure).

IPD Sharing Time Frame

please see www.probci.nl for procedure

IPD Sharing Access Criteria

please see www.probci.nl for procedure

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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