Predictive and Prognostic Biomarkers in Patients With Mycosis Fungoides and Sézary Syndrome.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorLund University Hospital
About this trial
A translational study for identification of prognostic and treatment-predictive biomarkers in Mycosis fungoides and Sézary syndrome.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
None
Trial 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.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Blood tests and testing of analysis of the lymphoma microenvironment in skin, skin barrier and skin microbiology profile.
Diagnostic testThe 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.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Patients with Mycosis fungoides and Sézary syndrome1 intervention
Group B: Healthy volontaires1 intervention
Trial outcomes
Primary outcomes
1
Identification of serum-protein markers.
Analysis of blood samples.
Time frame
Blood samples are taken at baseline.2
Identification of serum-protein markers.
Analysis of blood samples.
Time frame
Blood samples are taken at month 6.3
Identification of serum-protein markers.
Analysis of blood samples.
Time frame
Blood samples are taken at month 12.4
Identification of serum-protein markers.
Analysis of blood samples.
Time frame
Blood samples are taken at month 18.Secondary outcomes
1
Analysis of the lymphoma microenvironment in skin.
Analysis of lymphocyte subsets in blood.
Time frame
Blood samples are taken at baseline.2
Analysis of the lymphoma microenvironment in skin.
Analysis of lymphocyte subsets in blood.
Time frame
Blood samples are taken at month 6.3
Analysis of the lymphoma microenvironment in skin.
Analysis of lymphocyte subsets in blood.
Time frame
Blood samples are taken at month 12.4
Analysis of the lymphoma microenvironment in skin.
Analysis of lymphocyte subsets in blood.
Time frame
Blood samples are taken at month 18.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov