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

May 21, 2021 updated by: Lund University Hospital
A translational study for identification of prognostic and treatment-predictive biomarkers in Mycosis fungoides and Sézary syndrome.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Lund, Sweden, SE-221 85
        • Recruiting
        • Lund University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kristina Drott, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of serum-protein markers.
Time Frame: Blood samples are taken at baseline.
Analysis of blood samples.
Blood samples are taken at baseline.
Identification of serum-protein markers.
Time Frame: Blood samples are taken at month 6.
Analysis of blood samples.
Blood samples are taken at month 6.
Identification of serum-protein markers.
Time Frame: Blood samples are taken at month 12.
Analysis of blood samples.
Blood samples are taken at month 12.
Identification of serum-protein markers.
Time Frame: Blood samples are taken at month 18.
Analysis of blood samples.
Blood samples are taken at month 18.
Identification of serum-protein markers.
Time Frame: Blood samples are taken at month 24.
Analysis of blood samples.
Blood samples are taken at month 24.
Identification of serum-protein markers.
Time Frame: Blood samples are taken at month 30.
Analysis of blood samples.
Blood samples are taken at month 30.
Identification of serum-protein markers.
Time Frame: Blood samples are taken at month 36.
Analysis of blood samples.
Blood samples are taken at month 36.
Identification of immune cell profile-protein markers.
Time Frame: Blood samples are taken at baseline.
Analysis of blood samples.
Blood samples are taken at baseline.
Identification of immune cell profile-protein markers.
Time Frame: Blood samples are taken at month 6.
Analysis of blood samples.
Blood samples are taken at month 6.
Identification of immune cell profile-protein markers.
Time Frame: Blood samples are taken at month 12.
Analysis of blood samples.
Blood samples are taken at month 12.
Identification of immune cell profile-protein markers.
Time Frame: Blood samples are taken at month 18.
Analysis of blood samples.
Blood samples are taken at month 18.
Identification of immune cell profile-protein markers.
Time Frame: Blood samples are taken at month 24.
Analysis of blood samples.
Blood samples are taken at month 24.
Identification of immune cell profile-protein markers.
Time Frame: Blood samples are taken at month 30.
Analysis of blood samples.
Blood samples are taken at month 30.
Identification of immune cell profile-protein markers.
Time Frame: Blood samples are taken at month 36.
Analysis of blood samples.
Blood samples are taken at month 36.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of the lymphoma microenvironment in skin.
Time Frame: Blood samples are taken at baseline.
Analysis of lymphocyte subsets in blood.
Blood samples are taken at baseline.
Analysis of the lymphoma microenvironment in skin.
Time Frame: Blood samples are taken at month 6.
Analysis of lymphocyte subsets in blood.
Blood samples are taken at month 6.
Analysis of the lymphoma microenvironment in skin.
Time Frame: Blood samples are taken at month 12.
Analysis of lymphocyte subsets in blood.
Blood samples are taken at month 12.
Analysis of the lymphoma microenvironment in skin.
Time Frame: Blood samples are taken at month 18.
Analysis of lymphocyte subsets in blood.
Blood samples are taken at month 18.
Analysis of the lymphoma microenvironment in skin.
Time Frame: Blood samples are taken at month 24.
Analysis of lymphocyte subsets in blood.
Blood samples are taken at month 24.
Analysis of the lymphoma microenvironment in skin.
Time Frame: Blood samples are taken at month 30.
Analysis of lymphocyte subsets in blood.
Blood samples are taken at month 30.
Analysis of the lymphoma microenvironment in skin.
Time Frame: Blood samples are taken at month 36.
Analysis of lymphocyte subsets in blood.
Blood samples are taken at month 36.
Skin barrier and skin microbiology profile.
Time Frame: Is performed at baseline.
Skin barrier analyzed by transepidermal water loss of the skin on both healthy and affected skin.
Is performed at baseline.
Skin barrier and skin microbiology profile.
Time Frame: Is performed at month 6.
Skin barrier analyzed by transepidermal water loss of the skin on both healthy and affected skin.
Is performed at month 6.
Skin barrier and skin microbiology profile.
Time Frame: Is performed at month12.
Skin barrier analyzed by transepidermal water loss of the skin on both healthy and affected skin.
Is performed at month12.
Skin barrier and skin microbiology profile.
Time Frame: Is performed at month18.
Skin barrier analyzed by transepidermal water loss of the skin on both healthy and affected skin.
Is performed at month18.
Skin barrier and skin microbiology profile.
Time Frame: Is performed at month 24.
Skin barrier analyzed by transepidermal water loss of the skin on both healthy and affected skin.
Is performed at month 24.
Skin barrier and skin microbiology profile.
Time Frame: Is performed at month 30.
Skin barrier analyzed by transepidermal water loss of the skin on both healthy and affected skin.
Is performed at month 30.
Skin barrier and skin microbiology profile.
Time Frame: Is performed at month 36.
Skin barrier analyzed by transepidermal water loss of the skin on both healthy and affected skin.
Is performed at month 36.
Epigenetic changes in lymphoma T cells and host T cells.
Time Frame: Blood samples are taken at baseline.
Analysis of fresh blood.
Blood samples are taken at baseline.
Epigenetic changes in lymphoma T cells and host T cells.
Time Frame: Blood samples are taken at month 3.
Analysis of fresh blood.
Blood samples are taken at month 3.
Epigenetic changes in lymphoma T cells and host T cells.
Time Frame: Blood samples are taken at month 6.
Analysis of fresh blood.
Blood samples are taken at month 6.
Epigenetic changes in lymphoma T cells and host T cells.
Time Frame: Blood samples are taken at month 9.
Analysis of fresh blood.
Blood samples are taken at month 9.
Epigenetic changes in lymphoma T cells and host T cells.
Time Frame: Blood samples are taken at month 12.
Analysis of fresh blood.
Blood samples are taken at month 12.
Epigenetic changes in lymphoma T cells and host T cells.
Time Frame: Blood samples are taken at month 15.
Analysis of fresh blood.
Blood samples are taken at month 15.
Epigenetic changes in lymphoma T cells and host T cells.
Time Frame: Blood samples are taken at month 18.
Analysis of fresh blood.
Blood samples are taken at month 18.
Epigenetic changes in lymphoma T cells and host T cells.
Time Frame: Blood samples are taken at month 21.
Analysis of fresh blood.
Blood samples are taken at month 21.
Epigenetic changes in lymphoma T cells and host T cells.
Time Frame: Blood samples are taken at month 24.
Analysis of fresh blood.
Blood samples are taken at month 24.
Epigenetic changes in lymphoma T cells and host T cells.
Time Frame: Blood samples are taken at month 27.
Analysis of fresh blood.
Blood samples are taken at month 27.
Epigenetic changes in lymphoma T cells and host T cells.
Time Frame: Blood samples are taken at month 30.
Analysis of fresh blood.
Blood samples are taken at month 30.
Epigenetic changes in lymphoma T cells and host T cells.
Time Frame: Blood samples are taken at month 33.
Analysis of fresh blood.
Blood samples are taken at month 33.
Epigenetic changes in lymphoma T cells and host T cells.
Time Frame: Blood samples are taken at month 36.
Analysis of fresh blood.
Blood samples are taken at month 36.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lund University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2021

Primary Completion (Anticipated)

April 1, 2027

Study Completion (Anticipated)

April 1, 2027

Study Registration Dates

First Submitted

May 20, 2021

First Submitted That Met QC Criteria

May 21, 2021

First Posted (Actual)

May 27, 2021

Study Record Updates

Last Update Posted (Actual)

May 27, 2021

Last Update Submitted That Met QC Criteria

May 21, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Version 1.7

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Mycosis Fungoides

Clinical Trials on Blood tests and testing of analysis of the lymphoma microenvironment in skin, skin barrier and skin microbiology profile.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bulgaria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe