NCT04503577

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,600

participants targeted

Target at P75+ for all trials

Timeline
188mo left

Started Oct 2020

Longer than P75 for all trials

Geographic Reach
1 country

23 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Oct 2020Dec 2041

First Submitted

Initial submission to the registry

August 4, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 7, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

October 4, 2020

Completed
20.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2040

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2041

Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

20.3 years

First QC Date

August 4, 2020

Last Update Submit

August 5, 2025

Conditions

Bladder Cancer

Keywords

Bladder cancerProspective cohort

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Alive/death/emigrated

    10 years

Secondary Outcomes (4)

  • Progression-free survival

    10 yeas

  • Recurrence-free survival

    10 yeas

  • Health-related quality of life

    2 years

  • Cancer-specific health-related quality of life

    2 years

Study Arms (1)

Bladder cancer patients

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • Bladder cancer
  • Any stage except Ta
  • years or older
  • Written informed consent

You may not qualify if:

  • Note: participation in ProBCI does not exclude the patient from participation in other studies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Jeroen Bosch Hospital

's-Hertogenbosch, Netherlands

RECRUITING

ZGT

Almelo, Netherlands

RECRUITING

Meander Medical Center

Amersfoort, Netherlands

RECRUITING

Amsterdam UMC, location VUMC

Amsterdam, Netherlands

RECRUITING

Rijnstate

Arnhem, Netherlands

RECRUITING

Amphia Ziekenhuis

Breda, Netherlands

RECRUITING

Albert Schweitzer Hospital

Dordrecht, Netherlands

RECRUITING

Ziekenhuis Gelderse Vallei

Ede, Netherlands

RECRUITING

Treant Hospital

Emmen, Netherlands

RECRUITING

University Medical Center Groningen

Groningen, Netherlands

RECRUITING

Spaarne Gasthuis

Hoofddorp, Netherlands

NOT YET RECRUITING

Medisch Centrum Leeuwarden

Leeuwarden, Netherlands

RECRUITING

Alrijne Ziekenhuis

Leiderdorp, Netherlands

RECRUITING

Maastricht University Medical Center

Maastricht, Netherlands

RECRUITING

Canisius Wilhelmina Ziekenhuis

Nijmegen, Netherlands

RECRUITING

Radboud univerisity Medical Center

Nijmegen, Netherlands

RECRUITING

Erasmus Medical Center

Rotterdam, Netherlands

RECRUITING

Zuyderland

Sittard, Netherlands

RECRUITING

Elisabeth-TweeSteden Ziekenhuis

Tilburg, Netherlands

RECRUITING

University Medical Center Utrecht

Utrecht, Netherlands

RECRUITING

VieCuri

Venlo, Netherlands

RECRUITING

SKB Winterswijk

Winterswijk, Netherlands

RECRUITING

Isala

Zwolle, Netherlands

RECRUITING

Related Publications (2)

  • 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: 34006553DERIVED

  • 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: 33316557DERIVED

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Central Study Contacts

A. Richters, PhD

CONTACT

0031623237842a.richters@iknl.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
20 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2020

First Posted

August 7, 2020

Study Start

October 4, 2020

Primary Completion (Estimated)

December 31, 2040

Study Completion (Estimated)

December 31, 2041

Last Updated

August 11, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
Time Frame
please see www.probci.nl for procedure
Access Criteria
please see www.probci.nl for procedure
More information

Locations

NL(23)