Prospective Bladder Cancer Infrastructure (ProBCI)

Recruiting

• Conditions: Bladder Cancer

• Registration Number: NCT04503577
• Lead Sponsor: Prospective Bladder Cancer Infrastructure Foundation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-04
• Study First Submitted QC: 2020-08-04
• Study First Posted: 2020-08-07
• Study Start: 2020-10-04
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18
• Primary Completion: 2040-12-31
• Study Completion: 2041-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3600

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival	10 years	Alive/death/emigrated

Secondary Outcome Measures

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

Trial Locations

Locations (23)

Jeroen Bosch Hospital; 🇳🇱 's-Hertogenbosch, Netherlands

Amphia Ziekenhuis; 🇳🇱 Breda, Netherlands

Meander Medical Center; 🇳🇱 Amersfoort, Netherlands

Amsterdam UMC, location VUMC; 🇳🇱 Amsterdam, Netherlands

ZGT; 🇳🇱 Almelo, Netherlands

Treant Hospital; 🇳🇱 Emmen, Netherlands

Alrijne Ziekenhuis; 🇳🇱 Leiderdorp, Netherlands

Canisius Wilhelmina Ziekenhuis; 🇳🇱 Nijmegen, Netherlands

Radboud univerisity Medical Center; 🇳🇱 Nijmegen, Netherlands

Albert Schweitzer Hospital; 🇳🇱 Dordrecht, Netherlands

Maastricht University Medical Center; 🇳🇱 Maastricht, Netherlands

Rijnstate; 🇳🇱 Arnhem, Netherlands

Ziekenhuis Gelderse Vallei; 🇳🇱 Ede, Netherlands

Spaarne Gasthuis; 🇳🇱 Hoofddorp, Netherlands

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands

Medisch Centrum Leeuwarden; 🇳🇱 Leeuwarden, Netherlands

Zuyderland; 🇳🇱 Sittard, Netherlands

Elisabeth-TweeSteden Ziekenhuis; 🇳🇱 Tilburg, Netherlands

SKB Winterswijk; 🇳🇱 Winterswijk, Netherlands

Isala; 🇳🇱 Zwolle, Netherlands

VieCuri; 🇳🇱 Venlo, Netherlands

University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands