Bladder CancerCOMPETENCENCT05679557
Comprehensive Geriatric Assessment for Perioperative Optimization in Cystectomy
A study testing Perioperative geriatric assessment and intervention in people with Bladder Cancer, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
Patients with muscle-invasive bladder cancer are often older and multimorbid, thus in an increased risk of perioperative mortality and morbidity in relation to radical cystectomy (RC). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Perioperative geriatric assessment and intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2023to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients with muscle-invasive bladder cancer and scheduled radical cystectomy.
- Planned urinary diversion with an ileal conduit
- Age ≥ 65 years.
- Patients considered frail by G8 screening tool (total score ≤14).
Who cannot join
- Patients who refuse or are not able to provide informed consent.
- Patients who do not speak or understand Danish.
- Planned concomitant nephroureterectomy or other major surgical intervention at the same time as RC
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Odense University Hospital
Odense, 5000
Lasse Bro, MD
About this study
Patients with muscle-invasive bladder cancer are often older and multimorbid, thus in an increased risk of perioperative mortality and morbidity in relation to radical cystectomy (RC). The aim of the study is to investigate the effect of perioperative Comprehensive Geriatric Assessment (CGA) and tailored intervention in older, frail patients with bladder cancer undergoing RC.
Read the detailed description
Patients will be randomized 1:1 and allocated into either control or intervention study arm. The control group will receive perioperative "care as usual" according to exciting principles and guidelines. The intervention will comprise a preoperative, thorough geriatric, multidisciplinary assessment, focused on optimizing health issues of expected importance in further course of surgery. Furthermore, postoperative ward rounds by a geriatric team will be conducted. Thus, the course of treatment for each patient will be a close interdisciplinary collaboration.
- Conditions
- Bladder Cancer
- Being tested
- Perioperative geriatric assessment and intervention
- Keywords
- Frailty, Comprehensive Geriatric Assessment
- Medical subject headings
- Urinary Bladder Neoplasms, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perioperative geriatric assessment and interventionOther
The intervention will comprise a preoperative, thorough geriatric, multidisciplinary assessment (CGA) and tailored interventions, focused on optimizing health issues of expected importance in further course of surgery. Furthermore, postoperative ward rounds by a geriatric team will be conducted. Thus, the course of treatment for each patient will be a close interdisciplinary collaboration.
| Study group | Role | What they receive |
|---|---|---|
| Conventional | No intervention | Perioperative "care as usual" according to exciting principles and guidelines |
| Geriatric | Experimental | Perioperative geriatric assessment and tailored interventions in relation to radical cystectomy. Receives: Other: Perioperative geriatric assessment and intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days Alive and out of Hospital (DAOH)
Primary outcome will be DAOH counted from day of surgery until 90 days after surgery. DAOH as an endpoint combines the duration of hospital stay, the burden of subsequently readmissions and mortality, and hence is an expression for the expected reduction in medical postoperative complications.
Measured: Within 90 days after cystectomy
Secondary outcomes (8)
Days Alive and out of Hospital (DAOH)
Secondary outcome will be DAOH counted from day of surgery until 30 days after surgery.
Measured: Within 30 days after cystectomy
Complications
Number and severity (Clavien-Dindo grad I-V)
Measured: Within 30 and 90 days after cystectomy
Length of stay
Number of days hospitalized during the index hospitalization
Measured: Within 90 days after surgery
Hospital readmissions
Number of days admitted to hospital
Measured: Within 30 and 90 days after cystectomy
Patient Quality of Life
Quality of Life evaluated by the EuroQol 5D questionnaire (EQ-ED-5L)
Measured: Within 30 and 90 days postoperatively
Patient Quality of Life
Quality of Life evaluated by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ C30/BLM30 (muscle invasive bladder cancer)).
Measured: Within 30 and 90 days postoperatively
Mortality
Number
Measured: Within 30 and 90 days after cystectomy
Chair stand test (CST)
Physical function measured by 30-s CST
Measured: 3 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start1 Feb 2023
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, multicenter, randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus, Aalborg University Hospital, Odense University Hospital
- Responsible party
- Principal investigator, Jørgen Bjerggaard Jensen, Aarhus University Hospital
- Investigators
- Jørgen S Bjerggaard Jensen, Prof., DMSc, Principal investigator, Aarhus University Hospital and Aarhus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05679557
- Sponsor's protocol ID
- 1-10-72-182-22
- Acronym
- COMPETENCE
- Status last verified
- Sep 2025
- First submitted
- 20 Dec 2022
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Geriatric Assessment for Perioperative Optimization in Cystectomy
- ClinicalTrials.gov ID
- NCT05679557
- Acronym / sponsor ID
- COMPETENCE / 1-10-72-182-22
- Conditions
- Bladder Cancer
- Keywords
- Frailty, Comprehensive Geriatric Assessment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- University of Aarhus, Aalborg University Hospital, Odense University Hospital
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 11 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with muscle-invasive bladder cancer are often older and multimorbid, thus in an increased risk of perioperative mortality and morbidity in relation to radical cystectomy (RC). The aim of the study is to investigate the effect of perioperative Comprehensive Geriatric Assessment (CGA) and tailored intervention in older, frail patients with bladder cancer undergoing RC.
Detailed description
Patients will be randomized 1:1 and allocated into either control or intervention study arm. The control group will receive perioperative "care as usual" according to exciting principles and guidelines. The intervention will comprise a preoperative, thorough geriatric, multidisciplinary assessment, focused on optimizing health issues of expected importance in further course of surgery. Furthermore, postoperative ward rounds by a geriatric team will be conducted. Thus, the course of treatment for each patient will be a close interdisciplinary collaboration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prospective, multicenter, randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Conventional | No intervention | –Perioperative "care as usual" according to exciting principles and guidelines |
| Geriatric | Experimental | Other: Perioperative geriatric assessment and interventionPerioperative geriatric assessment and tailored interventions in relation to radical cystectomy. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Patients with muscle-invasive bladder cancer and scheduled radical cystectomy.
- Planned urinary diversion with an ileal conduit
- Age ≥ 65 years.
- Patients considered frail by G8 screening tool (total score ≤14).
Key exclusion criteria (3 listed)
- Patients who refuse or are not able to provide informed consent.
- Patients who do not speak or understand Danish.
- Planned concomitant nephroureterectomy or other major surgical intervention at the same time as RC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perioperative geriatric assessment and interventionThe intervention will comprise a preoperative, thorough geriatric, multidisciplinary assessment (CGA) and tailored interventions, focused on optimizing health issues of expected importance in further course of surgery. Furthermore, postoperative ward rounds by a geriatric team will be conducted. Thus, the course of treatment for each patient will be a close interdisciplinary collaboration. | Other | Geriatric |
Primary outcome
Days Alive and out of Hospital (DAOH)
Time frame: Within 90 days after cystectomy
Primary outcome will be DAOH counted from day of surgery until 90 days after surgery. DAOH as an endpoint combines the duration of hospital stay, the burden of subsequently readmissions and mortality, and hence is an expression for the expected reduction in medical postoperative complications.
8 secondary outcomes
Days Alive and out of Hospital (DAOH)
Time frame: Within 30 days after cystectomy
Complications
Time frame: Within 30 and 90 days after cystectomy
Length of stay
Time frame: Within 90 days after surgery
Hospital readmissions
Time frame: Within 30 and 90 days after cystectomy
Patient Quality of Life
Time frame: Within 30 and 90 days postoperatively
Patient Quality of Life
Time frame: Within 30 and 90 days postoperatively
Mortality
Time frame: Within 30 and 90 days after cystectomy
Chair stand test (CST)
Time frame: 3 weeks postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jørgen S Bjerggaard Jensen, Prof., DMSc principal investigator
Aarhus University Hospital and Aarhus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perioperative geriatric assessment and intervention in people with Bladder Cancer, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jørgen Bjerggaard Jensen, Prof., DMSc (+45 30915525, katans@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days Alive and out of Hospital (DAOH) (time frame: Within 90 days after cystectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026; AzTrials last refreshed its copy on 30 Oct 2026.