The Impact of Late Effects After Treatment for Bladder Ca... | NCT05195515

Studies
The Impact of Late Effects After Treatment for Bladder Cancer on Quality of Life

NCT05195515

Sponsor

Aarhus University Hospital

Status

Enrolling by invitation

Last Update Posted

Mar 3, 2026Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Bladder Cancer

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2022Actual

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Jan 7, 2022

First Submission Date that Met QC Criteria

Jan 7, 2022

First Posted Date

Jan 19, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 2, 2026

Last Update Posted Date

Mar 3, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jørgen Bjerggaard Jensen, Professor, DMSc, Aarhus University HospitalPrincipal Investigator

Lead Sponsor

Aarhus University HospitalOTHER

Collaborators

Name	Class
University of Aarhus	OTHER
National Research Center for Survivorship and Late Adverse Effects Following Pelvic Organ Cancer, Denmark	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Health-related Quality of Life	Changes in Quality of Life measured using validated instruments	5 years from baseline inclusion

Secondary Outcomes

Measure	Description	Time Frame
Prevalence of late effects	Based on Patient Reported Outcomes and medical records	5 years from baseline inclusion

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Known Alzheimers disease
Diagnosed other causes explaining the hematuria

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients over 18 years of age, referred due to hematuria

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jørgen Bjerggaard Jensen, Professor	Department of Urology, Aarhus University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Urology, Aarhus University Hospital		Aarhus N		8200	Denmark
Department of Urology, Regional Hospital Gødstrup

Condition Browse Module

MeSH Terms

ID	Term
D001749	Urinary Bladder Neoplasms

Ancestor Terms

ID	Term
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided