NCT05195515

Brief Summary

Bladder Cancer prognosis, treatment, and subsequent morbidity and mortality vary between the different stages, thus resulting in a different impact on patients' lives. There are some well known late effects of the treatments for bladder cancer, but the knowledge of their impact on patients Quality of Life is sparse. This study aims to determine the prevalence of late effects impact on Quality of Life and potential risk factors for impairment.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
17mo left

Started Jan 2022

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
enrolling by invitation

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 Progress76%
Jan 2022Dec 2027

Study Start

First participant enrolled

January 1, 2022

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 19, 2022

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

March 3, 2026

Status Verified

March 1, 2026

Enrollment Period

6 years

First QC Date

January 7, 2022

Last Update Submit

March 2, 2026

Conditions

Keywords

Quality of LifeBladder CancerLate effects

Outcome Measures

Primary Outcomes (1)

  • Health-related Quality of Life

    Changes in Quality of Life measured using validated instruments

    5 years from baseline inclusion

Secondary Outcomes (1)

  • Prevalence of late effects

    5 years from baseline inclusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients over 18 years of age, referred due to hematuria

You may qualify if:

  • Patients are eligible if they are referred to a hospital in the Central Region Denmark, due to hematuria between 01/01/2022 and 01/01/2023
  • Ability to understand written and oral Danish

You may not qualify if:

  • Known Alzheimers disease
  • Diagnosed other causes explaining the hematuria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Department of Urology, Aarhus University Hospital

Aarhus N, 8200, Denmark

Location

Department of Urology, Regional Hospital Gødstrup

Gødstrup, 7400, Denmark

Location

Department of Urology, Regional Hospital Horsens

Horsens, 8700, Denmark

Location

Department of Urology, Regional Hospital Randers

Randers, 8900, Denmark

Location

Department of Urology, Regional Hospital Viborg

Viborg, 8800, Denmark

Location

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

Study Officials

  • Jørgen Bjerggaard Jensen, Professor

    Department of Urology, Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, DMSc

Study Record Dates

First Submitted

January 7, 2022

First Posted

January 19, 2022

Study Start

January 1, 2022

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

March 3, 2026

Record last verified: 2026-03

Locations