The Importance of Muscle Function in Patients With Disseminated Bladder Cancer

NCT04144270 | Unknown

• 1 other identifier: 70298
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. It also evaluates biomarkers for sarcopenia.

Conditions

Urinary Bladder Neoplasm

Keywords

Urinary Bladder Neoplasm; Urothelium Neoplasm; Oncology; Muscle function; Sarcopenia

Outcome Measures

Primary Outcomes (1)

• Muscle mass

  We will describe if muscle mass at baseline is correlated to completion of planned systemic oncological treatment

  Up to 36 months

Secondary Outcomes (3)

• Muscle strength

  Up to 36 months

• Muscle mass changes during systemic oncological treatment

  Up to 36 months

• Muscle strength changes during systemic oncological treatment

  Up to 36 months

Study Arms (1)

Included patients

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

Other: Evaluation of muscle mass and muscle function

Interventions

Evaluation of muscle mass and muscle function OTHER

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

Included patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• Age \< 18

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Roche Pharma AG: collaborator
• Merck Sharp & Dohme LLC: collaborator
• Beckett Foundation: collaborator
• Onkologisk Forskningsfond: collaborator

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Neoplasms; Sarcopenia

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Lise Hoej Omland, MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Hoej Omland, MD

CONTACT

+45 35450782; lise.hoej.omland@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: October 30, 2019
• Study Start: November 18, 2019
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: November 20, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)