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

Lund University Hospital120 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

Mycosis Fungoides Sezary Syndrome

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Lund University Hospital

Lund, Sweden

RECRUITING

Outcomes

Primary Outcomes

Identification of serum-protein markers.

Analysis of blood samples.

Time frame: Blood samples are taken at baseline.

Identification of serum-protein markers.

Analysis of blood samples.

Time frame: Blood samples are taken at month 6.

Identification of serum-protein markers.

Analysis of blood samples.

Time frame: Blood samples are taken at month 12.

Identification of serum-protein markers.

Analysis of blood samples.

Time frame: Blood samples are taken at month 18.

Identification of serum-protein markers.

Analysis of blood samples.

Time frame: Blood samples are taken at month 24.

Identification of serum-protein markers.

Analysis of blood samples.

Time frame: Blood samples are taken at month 30.

Identification of serum-protein markers.

Analysis of blood samples.

Time frame: Blood samples are taken at month 36.

Identification of immune cell profile-protein markers.

Analysis of blood samples.

Time frame: Blood samples are taken at baseline.

Identification of immune cell profile-protein markers.

Analysis of blood samples.

Time frame: Blood samples are taken at month 6.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

Analysis of the lymphoma microenvironment in skin.

Analysis of lymphocyte subsets in blood.

Time frame: Blood samples are taken at baseline.

Analysis of the lymphoma microenvironment in skin.

Analysis of lymphocyte subsets in blood.

Time frame: Blood samples are taken at month 6.

Analysis of the lymphoma microenvironment in skin.

Analysis of lymphocyte subsets in blood.

Time frame: Blood samples are taken at month 12.

Analysis of the lymphoma microenvironment in skin.

Analysis of lymphocyte subsets in blood.

Time frame: Blood samples are taken at month 18.

Analysis of the lymphoma microenvironment in skin.

Analysis of lymphocyte subsets in blood.

Time frame: Blood samples are taken at month 24.

Analysis of the lymphoma microenvironment in skin.

Analysis of lymphocyte subsets in blood.

Time frame: Blood samples are taken at month 30.

Analysis of the lymphoma microenvironment in skin.

Analysis of lymphocyte subsets in blood.

Time frame: Blood samples are taken at month 36.

Skin barrier and skin microbiology profile.

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

Time frame: Is performed at baseline.

Skin barrier and skin microbiology profile.

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

Time frame: Is performed at month 6.

Skin barrier and skin microbiology profile.

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

Time frame: Is performed at month12.

Skin barrier and skin microbiology profile.

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

Time frame: Is performed at month18.

Skin barrier and skin microbiology profile.

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

Time frame: Is performed at month 24.

Skin barrier and skin microbiology profile.

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

Time frame: Is performed at month 30.

Skin barrier and skin microbiology profile.

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

Time frame: Is performed at month 36.