Clinical trial NCT04904146: Predictive and Prognostic Biomarkers in Patients With Mycosis Fungoides and Sézary Syndrome.
Official title: Predictive and Prognostic Biomarkers in Patients With Mycosis Fungoides and Sézary Syndrome.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mycosis Fungoides
Sezary Syndrome
Keywords: Skin lymphoma
Mycosis fungoides
Sezary syndrome
Translational research
Biomarkers
Treatment prediction
Lymphoma microenvironment
Skin neoplasms
Treatment
Lead sponsor: Lund University Hospital
Sponsor class: OTHER
First posted: 2021-05-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study 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.

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


Eligibility criteria: 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.

Primary outcomes:
measure: Identification of serum-protein markers.
timeFrame: Blood samples are taken at baseline.
measure: Identification of serum-protein markers.
timeFrame: Blood samples are taken at month 6.
measure: Identification of serum-protein markers.
timeFrame: Blood samples are taken at month 12.
measure: Identification of serum-protein markers.
timeFrame: Blood samples are taken at month 18.
measure: Identification of serum-protein markers.
timeFrame: Blood samples are taken at month 24.
measure: Identification of serum-protein markers.
timeFrame: Blood samples are taken at month 30.
measure: Identification of serum-protein markers.
timeFrame: Blood samples are taken at month 36.
measure: Identification of immune cell profile-protein markers.
timeFrame: Blood samples are taken at baseline.
measure: Identification of immune cell profile-protein markers.
timeFrame: Blood samples are taken at month 6.
measure: Identification of immune cell profile-protein markers.
timeFrame: Blood samples are taken at month 12.
measure: Identification of immune cell profile-protein markers.
timeFrame: Blood samples are taken at month 18.
measure: Identification of immune cell profile-protein markers.
timeFrame: Blood samples are taken at month 24.
measure: Identification of immune cell profile-protein markers.
timeFrame: Blood samples are taken at month 30.
measure: Identification of immune cell profile-protein markers.
timeFrame: Blood samples are taken at month 36.
Secondary outcomes:
measure: Analysis of the lymphoma microenvironment in skin.
timeFrame: Blood samples are taken at baseline.
measure: Analysis of the lymphoma microenvironment in skin.
timeFrame: Blood samples are taken at month 6.
measure: Analysis of the lymphoma microenvironment in skin.
timeFrame: Blood samples are taken at month 12.
measure: Analysis of the lymphoma microenvironment in skin.
timeFrame: Blood samples are taken at month 18.
measure: Analysis of the lymphoma microenvironment in skin.
timeFrame: Blood samples are taken at month 24.
measure: Analysis of the lymphoma microenvironment in skin.
timeFrame: Blood samples are taken at month 30.
measure: Analysis of the lymphoma microenvironment in skin.
timeFrame: Blood samples are taken at month 36.
measure: Skin barrier and skin microbiology profile.
timeFrame: Is performed at baseline.
measure: Skin barrier and skin microbiology profile.
timeFrame: Is performed at month 6.
measure: Skin barrier and skin microbiology profile.
timeFrame: Is performed at month12.
measure: Skin barrier and skin microbiology profile.
timeFrame: Is performed at month18.
measure: Skin barrier and skin microbiology profile.
timeFrame: Is performed at month 24.
measure: Skin barrier and skin microbiology profile.
timeFrame: Is performed at month 30.
measure: Skin barrier and skin microbiology profile.
timeFrame: Is performed at month 36.
measure: Epigenetic changes in lymphoma T cells and host T cells.
timeFrame: Blood samples are taken at baseline.
measure: Epigenetic changes in lymphoma T cells and host T cells.
timeFrame: Blood samples are taken at month 3.
measure: Epigenetic changes in lymphoma T cells and host T cells.
timeFrame: Blood samples are taken at month 6.
measure: Epigenetic changes in lymphoma T cells and host T cells.
timeFrame: Blood samples are taken at month 9.
measure: Epigenetic changes in lymphoma T cells and host T cells.
timeFrame: Blood samples are taken at month 12.
measure: Epigenetic changes in lymphoma T cells and host T cells.
timeFrame: Blood samples are taken at month 15.
measure: Epigenetic changes in lymphoma T cells and host T cells.
timeFrame: Blood samples are taken at month 18.
measure: Epigenetic changes in lymphoma T cells and host T cells.
timeFrame: Blood samples are taken at month 21.
measure: Epigenetic changes in lymphoma T cells and host T cells.
timeFrame: Blood samples are taken at month 24.
measure: Epigenetic changes in lymphoma T cells and host T cells.
timeFrame: Blood samples are taken at month 27.
measure: Epigenetic changes in lymphoma T cells and host T cells.
timeFrame: Blood samples are taken at month 30.
measure: Epigenetic changes in lymphoma T cells and host T cells.
timeFrame: Blood samples are taken at month 33.
measure: Epigenetic changes in lymphoma T cells and host T cells.
timeFrame: Blood samples are taken at month 36.
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Lund University Hospital
Study officials:
References: