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

Mycosis Fungoides Clinical Trial

— BIO-MUSE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04904146
• Other study ID #: Version 1.7
• Status: Recruiting
• Start date: April 2, 2021
• Est. completion date: April 2027

Study information

• Verified date: May 2021
• Source: Lund University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 2027
• Est. primary completion date: April 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mycoses
• Mycosis Fungoides
• Sezary Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Sweden	Lund University Hospital	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Lund University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of serum-protein markers.	Analysis of blood samples.	Blood samples are taken at baseline.
Primary	Identification of serum-protein markers.	Analysis of blood samples.	Blood samples are taken at month 6.
Primary	Identification of serum-protein markers.	Analysis of blood samples.	Blood samples are taken at month 12.
Primary	Identification of serum-protein markers.	Analysis of blood samples.	Blood samples are taken at month 18.
Primary	Identification of serum-protein markers.	Analysis of blood samples.	Blood samples are taken at month 24.
Primary	Identification of serum-protein markers.	Analysis of blood samples.	Blood samples are taken at month 30.
Primary	Identification of serum-protein markers.	Analysis of blood samples.	Blood samples are taken at month 36.
Primary	Identification of immune cell profile-protein markers.	Analysis of blood samples.	Blood samples are taken at baseline.
Primary	Identification of immune cell profile-protein markers.	Analysis of blood samples.	Blood samples are taken at month 6.
Primary	Identification of immune cell profile-protein markers.	Analysis of blood samples.	Blood samples are taken at month 12.
Primary	Identification of immune cell profile-protein markers.	Analysis of blood samples.	Blood samples are taken at month 18.
Primary	Identification of immune cell profile-protein markers.	Analysis of blood samples.	Blood samples are taken at month 24.
Primary	Identification of immune cell profile-protein markers.	Analysis of blood samples.	Blood samples are taken at month 30.
Primary	Identification of immune cell profile-protein markers.	Analysis of blood samples.	Blood samples are taken at month 36.
Secondary	Analysis of the lymphoma microenvironment in skin.	Analysis of lymphocyte subsets in blood.	Blood samples are taken at baseline.
Secondary	Analysis of the lymphoma microenvironment in skin.	Analysis of lymphocyte subsets in blood.	Blood samples are taken at month 6.
Secondary	Analysis of the lymphoma microenvironment in skin.	Analysis of lymphocyte subsets in blood.	Blood samples are taken at month 12.
Secondary	Analysis of the lymphoma microenvironment in skin.	Analysis of lymphocyte subsets in blood.	Blood samples are taken at month 18.
Secondary	Analysis of the lymphoma microenvironment in skin.	Analysis of lymphocyte subsets in blood.	Blood samples are taken at month 24.
Secondary	Analysis of the lymphoma microenvironment in skin.	Analysis of lymphocyte subsets in blood.	Blood samples are taken at month 30.
Secondary	Analysis of the lymphoma microenvironment in skin.	Analysis of lymphocyte subsets in blood.	Blood samples are taken at month 36.
Secondary	Skin barrier and skin microbiology profile.	Skin barrier analyzed by transepidermal water loss of the skin on both healthy and affected skin.	Is performed at baseline.
Secondary	Skin barrier and skin microbiology profile.	Skin barrier analyzed by transepidermal water loss of the skin on both healthy and affected skin.	Is performed at month 6.
Secondary	Skin barrier and skin microbiology profile.	Skin barrier analyzed by transepidermal water loss of the skin on both healthy and affected skin.	Is performed at month12.
Secondary	Skin barrier and skin microbiology profile.	Skin barrier analyzed by transepidermal water loss of the skin on both healthy and affected skin.	Is performed at month18.
Secondary	Skin barrier and skin microbiology profile.	Skin barrier analyzed by transepidermal water loss of the skin on both healthy and affected skin.	Is performed at month 24.
Secondary	Skin barrier and skin microbiology profile.	Skin barrier analyzed by transepidermal water loss of the skin on both healthy and affected skin.	Is performed at month 30.
Secondary	Skin barrier and skin microbiology profile.	Skin barrier analyzed by transepidermal water loss of the skin on both healthy and affected skin.	Is performed at month 36.
Secondary	Epigenetic changes in lymphoma T cells and host T cells.	Analysis of fresh blood.	Blood samples are taken at baseline.
Secondary	Epigenetic changes in lymphoma T cells and host T cells.	Analysis of fresh blood.	Blood samples are taken at month 3.
Secondary	Epigenetic changes in lymphoma T cells and host T cells.	Analysis of fresh blood.	Blood samples are taken at month 6.
Secondary	Epigenetic changes in lymphoma T cells and host T cells.	Analysis of fresh blood.	Blood samples are taken at month 9.
Secondary	Epigenetic changes in lymphoma T cells and host T cells.	Analysis of fresh blood.	Blood samples are taken at month 12.
Secondary	Epigenetic changes in lymphoma T cells and host T cells.	Analysis of fresh blood.	Blood samples are taken at month 15.
Secondary	Epigenetic changes in lymphoma T cells and host T cells.	Analysis of fresh blood.	Blood samples are taken at month 18.
Secondary	Epigenetic changes in lymphoma T cells and host T cells.	Analysis of fresh blood.	Blood samples are taken at month 21.
Secondary	Epigenetic changes in lymphoma T cells and host T cells.	Analysis of fresh blood.	Blood samples are taken at month 24.
Secondary	Epigenetic changes in lymphoma T cells and host T cells.	Analysis of fresh blood.	Blood samples are taken at month 27.
Secondary	Epigenetic changes in lymphoma T cells and host T cells.	Analysis of fresh blood.	Blood samples are taken at month 30.
Secondary	Epigenetic changes in lymphoma T cells and host T cells.	Analysis of fresh blood.	Blood samples are taken at month 33.
Secondary	Epigenetic changes in lymphoma T cells and host T cells.	Analysis of fresh blood.	Blood samples are taken at month 36.