NCT05150561

Brief Summary

PURPOSE: To evaluate the prevalence and prognostic value of sarcopenia in patients diagnosed with hematological cancer diseases.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
216

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 9, 2021

Completed
1.8 years until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

2.1 years

First QC Date

November 8, 2021

Last Update Submit

August 5, 2025

Conditions

Hematologic DiseasesAcute Myeloid LeukemiaAcute Lymphoid LeukemiaMyelodysplastic SyndromesLymphoma

Keywords

Hematological cancer diseasesMuscle massMuscle strengthComplicationsPatient reported outcomesPhysical function

Outcome Measures

Primary Outcomes (1)

  • Change in Whole body Lean body Mass

    Dual-energy X-ray Absorptiometry (DXA) scan

    Baseline and 6 months after treatment start

Secondary Outcomes (23)

  • Hospitalization duration

    1 year post treatment

  • Disease free survival

    1 year post treatment

  • Overall survival

    1 year post treatment

  • Change in appendicular lean mass

    Baseline and 6 after treatment start

  • Change in whole body fat percentage

    Baseline and 6 months after treatment start

  • +18 more secondary outcomes

Study Arms (3)

Cohort I - Patients newly diagnosed with malignant lymphoma (n=72)

These patients will undergo two assessments: A baseline-assessment prior to treatment for the hematologic cancer disease and a follow-up assessment at 6 months after treatment start

Cohort II - Patients newly diagnosed with acute leukaemia (n=72)

These patients will undergo two assessments: A baseline-assessment prior to treatment for the hematologic cancer disease and a follow-up assessment at 6 months after treatment start

Cohort III - Patients newly diagnosed with multiple myeloma (n=72)

These patients will undergo two assessments: A baseline-assessment prior to treatment for the hematologic cancer disease and a follow-up assessment at 6 months after treatment start

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with malignant lymphomas, acute leukaemia and multiple myeloma referred to treatment.

You may qualify if:

  • Patients diagnosed with malignant lymphomas, acute leukaemia and multiple myeloma referred to treatment at the Department of Haematology, Rigshospitalet.

You may not qualify if:

  • Age: \<18
  • Pregnancy
  • Physical or mental disabilities precluding test of muscle function
  • Inability to read and understand Danish.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Hematologic DiseasesLeukemia, Myeloid, AcutePrecursor Cell Lymphoblastic Leukemia-LymphomaMyelodysplastic SyndromesLymphoma

Condition Hierarchy (Ancestors)

Hemic and Lymphatic DiseasesLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesBone Marrow Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Researcher

Study Record Dates

First Submitted

November 8, 2021

First Posted

December 9, 2021

Study Start

October 1, 2023

Primary Completion

October 30, 2025

Study Completion

May 1, 2026

Last Updated

August 11, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Not provided

Locations

DK(1)