Urinary Bladder NeoplasmNCT04144270
The Importance of Muscle Function in Patients With Disseminated Bladder Cancer
An observational study of Urinary Bladder Neoplasm, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
This study investigates if reduced muscle mass and muscle function predispose to poor completion of oncological treatment in patients with bladder cancer (including cancer of the renal pelvis, ureter and urethra) and if muscle mass and muscle function change during oncological treatment in these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Bladder Neoplasm
- What is being tested?
- Evaluation of muscle mass and muscle function
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 18 Nov 2019to Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with localized cancer in the urinary tract undergoing neoadjuvant chemotherapy prior to radical cystektomy or patients with disseminated disease undergoing chemotherapy or immunotherapy. Patients are identified and included from Department of Oncology, Rigshospitalet, Copenhagen, Denmark.
Who may be able to join
- Informed consent
- Age ≥ 18 år
- Histologically verified cancer of the renal pelvis, ureter, bladder or urethra regardless of type of histology
- ECOG performance status 0 - 3
- Meet the requirements for receiving oncological treatment (neoadjuvant chemotherapy for localized disease, chemotherapy or immunotherapy for disseminated disease).
Who cannot join
- Age < 18
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen, 2100
Lise Hoej Omland, MD, +45 35450782, lise.hoej.omland@regionh.dk
Helle Pappot, Professor, helle.pappot@regionh.dk
About this study
This study investigates if reduced muscle mass and muscle function predispose to poor completion of oncological treatment in patients with bladder cancer (including cancer of the renal pelvis, ureter and urethra) and if muscle mass and muscle function change during oncological treatment in these patients. It also evaluates biomarkers for sarcopenia.
- Conditions
- Urinary Bladder Neoplasm
- Being tested
- Evaluation of muscle mass and muscle function
- Keywords
- Urinary Bladder Neoplasm, Urothelium Neoplasm, Oncology, Muscle function, Sarcopenia
- Medical subject headings
- Urinary Bladder Neoplasms, Neoplasms, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of muscle mass and muscle functionOther
Included patients have their muscle mass and muscle function evaluated before start on and after completion of oncological treatment.
| Study group | Role | What they receive |
|---|---|---|
| Included patients | One-arm study. All included patients will have muscle mass and muscle function evaluated Receives: Other: Evaluation of muscle mass and muscle function |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle mass
We will describe if muscle mass at baseline is correlated to completion of planned systemic oncological treatment
Measured: Up to 36 months
Secondary outcomes (3)
Muscle strength
We will describe if muscle strength at baseline is correlated to completion of planned systemic oncological treatment
Measured: Up to 36 months
Muscle mass changes during systemic oncological treatment
We will describe if muscle mass change during systemic oncological treatment
Measured: Up to 36 months
Muscle strength changes during systemic oncological treatment
We will describe if muscle mass change during systemic oncological treatment
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start18 Nov 2019 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder NeoplasmStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG, Merck Sharp & Dohme LLC, Beckett Foundation, Onkologisk Forskningsfond
- Responsible party
- Principal investigator, Lise Hoej Omland, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Lise Hoej Omland, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04144270
- Sponsor's protocol ID
- 70298
- Status last verified
- Nov 2019
- First submitted
- 1 Oct 2019
- Last updated
- 20 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- 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 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Importance of Muscle Function in Patients With Disseminated Bladder Cancer
- ClinicalTrials.gov ID
- NCT04144270
- Acronym / sponsor ID
- 70298
- Conditions
- Urinary Bladder Neoplasm
- Keywords
- Urinary Bladder Neoplasm, Urothelium Neoplasm, Oncology, Muscle function, Sarcopenia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Roche Pharma AG, Merck Sharp & Dohme LLC, Beckett Foundation, Onkologisk Forskningsfond
- Study start
- 18 Nov 2019 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 30 Oct 2019 (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.
This study investigates if reduced muscle mass and muscle function predispose to poor completion of oncological treatment in patients with bladder cancer (including cancer of the renal pelvis, ureter and urethra) and if muscle mass and muscle function change during oncological treatment in these patients. It also evaluates biomarkers for sarcopenia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Included patients | – | Other: Evaluation of muscle mass and muscle functionOne-arm study. All included patients will have muscle mass and muscle function evaluated |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with localized cancer in the urinary tract undergoing neoadjuvant chemotherapy prior to radical cystektomy or patients with disseminated disease undergoing chemotherapy or immunotherapy. Patients are identified and included from Department of Oncology, Rigshospitalet, Copenhagen, Denmark.
Key inclusion criteria (5 listed)
- Informed consent
- Age ≥ 18 år
- Histologically verified cancer of the renal pelvis, ureter, bladder or urethra regardless of type of histology
- ECOG performance status 0 - 3
- Meet the requirements for receiving oncological treatment (neoadjuvant chemotherapy for localized disease, chemotherapy or immunotherapy for disseminated disease).
Key exclusion criteria (1 listed)
- Age < 18
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 |
|---|---|---|
| Evaluation of muscle mass and muscle functionIncluded patients have their muscle mass and muscle function evaluated before start on and after completion of oncological treatment. | Other | Included patients |
Primary outcome
Muscle mass
Time frame: Up to 36 months
We will describe if muscle mass at baseline is correlated to completion of planned systemic oncological treatment
3 secondary outcomes
Muscle strength
Time frame: Up to 36 months
Muscle mass changes during systemic oncological treatment
Time frame: Up to 36 months
Muscle strength changes during systemic oncological treatment
Time frame: Up to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
- 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. This study is not recruiting at the moment.
Lise Hoej Omland, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Bladder Neoplasm, run by Copenhagen University Hospital, Rigshospitalet 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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 20 Nov 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise Hoej Omland, MD (+45 35450782, lise.hoej.omland@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle mass (time frame: Up to 36 months). 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 20 Nov 2019.