BIO-MUSE: Predictive and Prognostic Biomarkers in Patients With Mycosis Fungoides and Sézary Syndrome.

• Sponsor: Lund University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04904146
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Anticipated Duration (Months): 72
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Mycosis Fungoides; Sezary Syndrome	Diagnostic Test: Blood tests and testing of analysis of the lymphoma microenvironment in skin, skin barrier and skin microbiology profile.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 120 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Predictive and Prognostic Biomarkers in Patients With Mycosis Fungoides and Sézary Syndrome.
• Actual Study Start Date: Apr 2, 2021
• Anticipated Primary Completion Date: Apr 1, 2027
• Anticipated Study Completion Date: Apr 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
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.; 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 volontaires	Diagnostic Test: Blood tests and testing of analysis of the lymphoma microenvironment in skin, skin barrier and skin microbiology profile.; 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.

Outcome Measures

Primary Outcome Measures

1. Identification of serum-protein markers. [Blood samples are taken at baseline.]

   Analysis of blood samples.

2. Identification of serum-protein markers. [Blood samples are taken at month 6.]

   Analysis of blood samples.

3. Identification of serum-protein markers. [Blood samples are taken at month 12.]

   Analysis of blood samples.

4. Identification of serum-protein markers. [Blood samples are taken at month 18.]

   Analysis of blood samples.

5. Identification of serum-protein markers. [Blood samples are taken at month 24.]

   Analysis of blood samples.

6. Identification of serum-protein markers. [Blood samples are taken at month 30.]

   Analysis of blood samples.

7. Identification of serum-protein markers. [Blood samples are taken at month 36.]

   Analysis of blood samples.

8. Identification of immune cell profile-protein markers. [Blood samples are taken at baseline.]

   Analysis of blood samples.

9. Identification of immune cell profile-protein markers. [Blood samples are taken at month 6.]

   Analysis of blood samples.

10. Identification of immune cell profile-protein markers. [Blood samples are taken at month 12.]

    Analysis of blood samples.

11. Identification of immune cell profile-protein markers. [Blood samples are taken at month 18.]

    Analysis of blood samples.

12. Identification of immune cell profile-protein markers. [Blood samples are taken at month 24.]

    Analysis of blood samples.

13. Identification of immune cell profile-protein markers. [Blood samples are taken at month 30.]

    Analysis of blood samples.

14. Identification of immune cell profile-protein markers. [Blood samples are taken at month 36.]

    Analysis of blood samples.

Secondary Outcome Measures

1. Analysis of the lymphoma microenvironment in skin. [Blood samples are taken at baseline.]

   Analysis of lymphocyte subsets in blood.

2. Analysis of the lymphoma microenvironment in skin. [Blood samples are taken at month 6.]

   Analysis of lymphocyte subsets in blood.

3. Analysis of the lymphoma microenvironment in skin. [Blood samples are taken at month 12.]

   Analysis of lymphocyte subsets in blood.

4. Analysis of the lymphoma microenvironment in skin. [Blood samples are taken at month 18.]

   Analysis of lymphocyte subsets in blood.

5. Analysis of the lymphoma microenvironment in skin. [Blood samples are taken at month 24.]

   Analysis of lymphocyte subsets in blood.

6. Analysis of the lymphoma microenvironment in skin. [Blood samples are taken at month 30.]

   Analysis of lymphocyte subsets in blood.

7. Analysis of the lymphoma microenvironment in skin. [Blood samples are taken at month 36.]

   Analysis of lymphocyte subsets in blood.

8. Skin barrier and skin microbiology profile. [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. [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. [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. [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. [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. [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. [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. [Blood samples are taken at baseline.]

    Analysis of fresh blood.

16. Epigenetic changes in lymphoma T cells and host T cells. [Blood samples are taken at month 3.]

    Analysis of fresh blood.

17. Epigenetic changes in lymphoma T cells and host T cells. [Blood samples are taken at month 6.]

    Analysis of fresh blood.

18. Epigenetic changes in lymphoma T cells and host T cells. [Blood samples are taken at month 9.]

    Analysis of fresh blood.

19. Epigenetic changes in lymphoma T cells and host T cells. [Blood samples are taken at month 12.]

    Analysis of fresh blood.

20. Epigenetic changes in lymphoma T cells and host T cells. [Blood samples are taken at month 15.]

    Analysis of fresh blood.

21. Epigenetic changes in lymphoma T cells and host T cells. [Blood samples are taken at month 18.]

    Analysis of fresh blood.

22. Epigenetic changes in lymphoma T cells and host T cells. [Blood samples are taken at month 21.]

    Analysis of fresh blood.

23. Epigenetic changes in lymphoma T cells and host T cells. [Blood samples are taken at month 24.]

    Analysis of fresh blood.

24. Epigenetic changes in lymphoma T cells and host T cells. [Blood samples are taken at month 27.]

    Analysis of fresh blood.

25. Epigenetic changes in lymphoma T cells and host T cells. [Blood samples are taken at month 30.]

    Analysis of fresh blood.

26. Epigenetic changes in lymphoma T cells and host T cells. [Blood samples are taken at month 33.]

    Analysis of fresh blood.

27. Epigenetic changes in lymphoma T cells and host T cells. [Blood samples are taken at month 36.]

    Analysis of fresh blood.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lund University Hospital	Lund		Sweden	SE-221 85

Sponsors and Collaborators

• Lund University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lund University Hospital
• ClinicalTrials.gov Identifier: NCT04904146
• Other Study ID Numbers: Version 1.7
• First Posted: May 27, 2021
• Last Update Posted: May 27, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Lund University Hospital: Skin lymphoma; Mycosis fungoides; Sezary syndrome; Translational research; Biomarkers; Treatment prediction; Lymphoma microenvironment; Skin neoplasms; Treatment
• Additional relevant MeSH terms: Mycoses; Mycosis Fungoides; Sezary Syndrome; Syndrome

Study Results

No Results Posted as of May 27, 2021