The Importance of Muscle Function in Patients With Disseminated Bladder Cancer

November 18, 2019 updated by: Lise Hoej Omland, Rigshospitalet, Denmark
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Included patients
One-arm study. All included patients will have muscle mass and muscle function evaluated
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle strength
Time Frame: Up to 36 months
We will describe if muscle strength at baseline is correlated to completion of planned systemic oncological treatment
Up to 36 months
Muscle mass changes during systemic oncological treatment
Time Frame: Up to 36 months
We will describe if muscle mass change during systemic oncological treatment
Up to 36 months
Muscle strength changes during systemic oncological treatment
Time Frame: Up to 36 months
We will describe if muscle mass change during systemic oncological treatment
Up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

Merck Sharp & Dohme LLC
Roche Pharma AG
Beckett Foundation
Onkologisk Forskningsfond

Investigators

  • Principal Investigator: Lise Hoej Omland, MD, Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 18, 2019

Primary Completion (Anticipated)

April 1, 2021

Study Completion (Anticipated)

April 1, 2021

Study Registration Dates

First Submitted

October 1, 2019

First Submitted That Met QC Criteria

October 28, 2019

First Posted (Actual)

October 30, 2019

Study Record Updates

Last Update Posted (Actual)

November 20, 2019

Last Update Submitted That Met QC Criteria

November 18, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 70298

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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