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NCT Number: NCT04904146

Predictive and Prognostic Biomarkers in Patients With Mycosis Fungoides and Sézary Syndrome.

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

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Key information

Conditions

Mycosis Fungoides Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Sezary Syndrome Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

Not applicable. No exclusion criteria are specified.

Treatment and study plan

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.

Primary outcomes

  1. Identification of serum-protein markers.

    Time frame: Blood samples are taken at baseline.

    Analysis of blood samples.

  2. Identification of serum-protein markers.

    Time frame: Blood samples are taken at month 6.

    Analysis of blood samples.

  3. Identification of serum-protein markers.

    Time frame: Blood samples are taken at month 12.

    Analysis of blood samples.

  4. Identification of serum-protein markers.

    Time frame: Blood samples are taken at month 18.

    Analysis of blood samples.

  5. Identification of serum-protein markers.

    Time frame: Blood samples are taken at month 24.

    Analysis of blood samples.

  6. Identification of serum-protein markers.

    Time frame: Blood samples are taken at month 30.

    Analysis of blood samples.

  7. Identification of serum-protein markers.

    Time frame: Blood samples are taken at month 36.

    Analysis of blood samples.

  8. Identification of immune cell profile-protein markers.

    Time frame: Blood samples are taken at baseline.

    Analysis of blood samples.

  9. Identification of immune cell profile-protein markers.

    Time frame: Blood samples are taken at month 6.

    Analysis of blood samples.

  10. Identification of immune cell profile-protein markers.

    Time frame: Blood samples are taken at month 12.

    Analysis of blood samples.

  11. Identification of immune cell profile-protein markers.

    Time frame: Blood samples are taken at month 18.

    Analysis of blood samples.

  12. Identification of immune cell profile-protein markers.

    Time frame: Blood samples are taken at month 24.

    Analysis of blood samples.

  13. Identification of immune cell profile-protein markers.

    Time frame: Blood samples are taken at month 30.

    Analysis of blood samples.

  14. Identification of immune cell profile-protein markers.

    Time frame: Blood samples are taken at month 36.

    Analysis of blood samples.

Secondary outcomes

  1. Analysis of the lymphoma microenvironment in skin.

    Time frame: Blood samples are taken at baseline.

    Analysis of lymphocyte subsets in blood.

  2. Analysis of the lymphoma microenvironment in skin.

    Time frame: Blood samples are taken at month 6.

    Analysis of lymphocyte subsets in blood.

  3. Analysis of the lymphoma microenvironment in skin.

    Time frame: Blood samples are taken at month 12.

    Analysis of lymphocyte subsets in blood.

  4. Analysis of the lymphoma microenvironment in skin.

    Time frame: Blood samples are taken at month 18.

    Analysis of lymphocyte subsets in blood.

  5. Analysis of the lymphoma microenvironment in skin.

    Time frame: Blood samples are taken at month 24.

    Analysis of lymphocyte subsets in blood.

  6. Analysis of the lymphoma microenvironment in skin.

    Time frame: Blood samples are taken at month 30.

    Analysis of lymphocyte subsets in blood.

  7. Analysis of the lymphoma microenvironment in skin.

    Time frame: Blood samples are taken at month 36.

    Analysis of lymphocyte subsets in blood.

  8. Skin barrier and skin microbiology profile.

    Time frame: Is performed at baseline.

    Skin barrier analyzed by transepidermal water loss of the skin on both healthy and affected skin.

  9. Skin barrier and skin microbiology profile.

    Time frame: Is performed at month 6.

    Skin barrier analyzed by transepidermal water loss of the skin on both healthy and affected skin.

  10. Skin barrier and skin microbiology profile.

    Time frame: Is performed at month12.

    Skin barrier analyzed by transepidermal water loss of the skin on both healthy and affected skin.

  11. Skin barrier and skin microbiology profile.

    Time frame: Is performed at month18.

    Skin barrier analyzed by transepidermal water loss of the skin on both healthy and affected skin.

  12. Skin barrier and skin microbiology profile.

    Time frame: Is performed at month 24.

    Skin barrier analyzed by transepidermal water loss of the skin on both healthy and affected skin.

  13. Skin barrier and skin microbiology profile.

    Time frame: Is performed at month 30.

    Skin barrier analyzed by transepidermal water loss of the skin on both healthy and affected skin.

  14. Skin barrier and skin microbiology profile.

    Time frame: Is performed at month 36.

    Skin barrier analyzed by transepidermal water loss of the skin on both healthy and affected skin.

  15. Epigenetic changes in lymphoma T cells and host T cells.

    Time frame: Blood samples are taken at baseline.

    Analysis of fresh blood.

  16. Epigenetic changes in lymphoma T cells and host T cells.

    Time frame: Blood samples are taken at month 3.

    Analysis of fresh blood.

  17. Epigenetic changes in lymphoma T cells and host T cells.

    Time frame: Blood samples are taken at month 6.

    Analysis of fresh blood.

  18. Epigenetic changes in lymphoma T cells and host T cells.

    Time frame: Blood samples are taken at month 9.

    Analysis of fresh blood.

  19. Epigenetic changes in lymphoma T cells and host T cells.

    Time frame: Blood samples are taken at month 12.

    Analysis of fresh blood.

  20. Epigenetic changes in lymphoma T cells and host T cells.

    Time frame: Blood samples are taken at month 15.

    Analysis of fresh blood.

  21. Epigenetic changes in lymphoma T cells and host T cells.

    Time frame: Blood samples are taken at month 18.

    Analysis of fresh blood.

  22. Epigenetic changes in lymphoma T cells and host T cells.

    Time frame: Blood samples are taken at month 21.

    Analysis of fresh blood.

  23. Epigenetic changes in lymphoma T cells and host T cells.

    Time frame: Blood samples are taken at month 24.

    Analysis of fresh blood.

  24. Epigenetic changes in lymphoma T cells and host T cells.

    Time frame: Blood samples are taken at month 27.

    Analysis of fresh blood.

  25. Epigenetic changes in lymphoma T cells and host T cells.

    Time frame: Blood samples are taken at month 30.

    Analysis of fresh blood.

  26. Epigenetic changes in lymphoma T cells and host T cells.

    Time frame: Blood samples are taken at month 33.

    Analysis of fresh blood.

  27. Epigenetic changes in lymphoma T cells and host T cells.

    Time frame: Blood samples are taken at month 36.

    Analysis of fresh blood.

Sponsors and collaborators

Lead sponsor

Lund University Hospital

Other

Registry information

Acronym: BIO-MUSE

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
May 27, 2021
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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