NCT04904146

Brief Summary

A translational study for identification of prognostic and treatment-predictive biomarkers in Mycosis fungoides and Sézary syndrome.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
11mo left

Started Apr 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
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

Study Progress85%
Apr 2021Apr 2027

Study Start

First participant enrolled

April 2, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 27, 2021

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

March 10, 2025

Status Verified

March 1, 2025

Enrollment Period

6 years

First QC Date

May 20, 2021

Last Update Submit

March 5, 2025

Conditions

Mycosis FungoidesSezary Syndrome

Keywords

Skin lymphomaMycosis fungoidesSezary syndromeTranslational researchBiomarkersTreatment predictionLymphoma microenvironmentSkin neoplasmsTreatment

Outcome Measures

Primary Outcomes (14)

  • Identification of serum-protein markers.

    Analysis of blood samples.

    Blood samples are taken at baseline.

  • Identification of serum-protein markers.

    Analysis of blood samples.

    Blood samples are taken at month 6.

  • Identification of serum-protein markers.

    Analysis of blood samples.

    Blood samples are taken at month 12.

  • Identification of serum-protein markers.

    Analysis of blood samples.

    Blood samples are taken at month 18.

  • Identification of serum-protein markers.

    Analysis of blood samples.

    Blood samples are taken at month 24.

  • Identification of serum-protein markers.

    Analysis of blood samples.

    Blood samples are taken at month 30.

  • Identification of serum-protein markers.

    Analysis of blood samples.

    Blood samples are taken at month 36.

  • Identification of immune cell profile-protein markers.

    Analysis of blood samples.

    Blood samples are taken at baseline.

  • Identification of immune cell profile-protein markers.

    Analysis of blood samples.

    Blood samples are taken at month 6.

  • Identification of immune cell profile-protein markers.

    Analysis of blood samples.

    Blood samples are taken at month 12.

  • Identification of immune cell profile-protein markers.

    Analysis of blood samples.

    Blood samples are taken at month 18.

  • Identification of immune cell profile-protein markers.

    Analysis of blood samples.

    Blood samples are taken at month 24.

  • Identification of immune cell profile-protein markers.

    Analysis of blood samples.

    Blood samples are taken at month 30.

  • Identification of immune cell profile-protein markers.

    Analysis of blood samples.

    Blood samples are taken at month 36.

Secondary Outcomes (27)

  • Analysis of the lymphoma microenvironment in skin.

    Blood samples are taken at baseline.

  • Analysis of the lymphoma microenvironment in skin.

    Blood samples are taken at month 6.

  • Analysis of the lymphoma microenvironment in skin.

    Blood samples are taken at month 12.

  • Analysis of the lymphoma microenvironment in skin.

    Blood samples are taken at month 18.

  • Analysis of the lymphoma microenvironment in skin.

    Blood samples are taken at month 24.

  • +22 more secondary outcomes

Study Arms (2)

Patients with Mycosis fungoides and Sézary syndrome

Diagnostic Test: Blood tests and testing of analysis of the lymphoma microenvironment in skin, skin barrier and skin microbiology profile.

Healthy volontaires

Diagnostic Test: Blood tests and testing of analysis of the lymphoma microenvironment in skin, skin barrier and skin microbiology profile.

Interventions

Blood tests and testing of analysis of the lymphoma microenvironment in skin, skin barrier and skin microbiology profile.DIAGNOSTIC_TEST

The study aims to perform systematic translational sampling of each patient from study start until end-of-study, or at longest for a three year period for each patient. Treatment will be performed according to clinical routine.

Healthy volontairesPatients with Mycosis fungoides and Sézary syndrome

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with mycosis fungoides and Sézary syndrome (n=120) are recruited in the study. As a control group, healthy volonteers (n=20) are recruited.

You may qualify if:

  • Age 18-100 years
  • Histologically confirmed (according to the World Health Organization (WHO)/EORTC classification) MF/SS stages I-IV
  • WHO performance status 0 -3
  • Absence of psychiatric illness or condition which could interfere with the subjects' ability to understand the requirements of the study.
  • Written informed consent according to International Conference on Harmonization (ICH)/(Good Clinical Practice (GCP), and Swedish regulations
  • No minimum or maximum required routine laboratory data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lund University Hospital

Lund, SE-221 85, Sweden

RECRUITING

Related Publications (1)

  • Belfrage E, Ek S, Johansson A, Brauner H, Sonesson A, Drott K. Predictive and Prognostic Biomarkers in Patients With Mycosis Fungoides and Sezary Syndrome (BIO-MUSE): Protocol for a Translational Study. JMIR Res Protoc. 2024 Apr 4;13:e55723. doi: 10.2196/55723.

    PMID: 38436589DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

• Lymphocyte subpopulations: * Basic examination lymphocytes: CD3, CD4, CD8, CD19, CD16/56 * T regs: CD4, CD25, CD194, CD127, CD45RO, HLA-DR * Naive and memory T-cells including TH1, TH2, TH17: CD4, CD8, CD197, CD45RA, CD183, CD196 * Follicular helper T cells: CD4, CD185 * T-cells : CD4, CD8, CD197, CD45RA, CD38, HLA-DR * Other leukocytes, at the discretion of the treating physician * sILR2R, IL6, IL1 beta, IL-8, IL10, TARC

MeSH Terms

Conditions

Mycosis FungoidesSezary SyndromeLymphoma, T-Cell, CutaneousSkin Neoplasms

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2021

First Posted

May 27, 2021

Study Start

April 2, 2021

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

March 10, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)