The Importance of Muscle Function in Patients With Disseminated Bladder Cancer

NCT ID: NCT04144270

Last Updated: 2019-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-18

Study Completion Date

2021-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Urinary Bladder Neoplasm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Included patients

One-arm study. All included patients will have muscle mass and muscle function evaluated

Evaluation of muscle mass and muscle function

Intervention Type OTHER

Included patients have their muscle mass and muscle function evaluated before start on and after completion of oncological treatment.

Interventions

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Evaluation of muscle mass and muscle function

Included patients have their muscle mass and muscle function evaluated before start on and after completion of oncological treatment.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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).

Exclusion Criteria

* Age \< 18
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Roche Pharma AG

INDUSTRY

Sponsor Role collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Beckett Foundation

OTHER

Sponsor Role collaborator

Onkologisk Forskningsfond

UNKNOWN

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Lise Hoej Omland

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lise Hoej Omland, MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

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Rigshospitalet

Copenhagen, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Lise Hoej Omland, MD

Role: CONTACT

+45 35450782

Facility Contacts

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Lise Hoej Omland, MD

Role: primary

+45 35450782

Helle Pappot, Professor

Role: backup

Other Identifiers

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70298

Identifier Type: -

Identifier Source: org_study_id

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