Diagnostic Classifier for Cutaneous T-cell Lymphomas

Rekrutierend

NCT-Nummer:
NCT04491825

Studienbeginn:
Februar 2021

Letztes Update:
05.04.2022

Wirkstoff:
-

Indikation (Clinical Trials):
Mycoses, Lymphoma, T-Cell, Mycosis Fungoides, Lymphoma, T-Cell, Cutaneous

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Medical University of Vienna

Collaborator:
-

Kontakt

Patrick M Brunner, MD, MSc
Kontakt:
Phone: +43140400
Phone (ext.): 77020
E-Mail: patrick.brunner@meduniwien.ac.at» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Medical University of Vienna
1090 Vienna
AustriaRekrutierend» Google-Maps
Ansprechpartner:
Patrick Brunner, MD, MSc
Phone: +436644605954
E-Mail: patrick.brunner@meduniwien.ac.at» Ansprechpartner anzeigen

Studien-Informationen

Brief Summary:

Primary cutaneous T-cell lymphomas (CTCL) are a form of skin cancer that is derived from

immune cells. The most common form of CTCL is mycosis fungoides (MF). While initially

confined to the skin, MF may spread to lymph nodes, blood or inner organs, resulting in an

overall poor prognosis for the patient. Thus, being a potentially lethal disease, an early

and correct diagnosis of MF has very important implications for the patient. However,

diagnosis of early MF is often difficult, as it usually shows a close resemblance to benign

inflammatory conditions such as eczema and psoriasis. Strikingly, it takes an average of 3-6

(!) years from the appearance of the first skin lesions until a diagnosis of MF can be made.

For this reason, a test to distinguishing early MF from benign inflammatory conditions is

urgently mandated. By using skin suction blister fluid as well as skin biopsies from patients

with MF, eczema and psoriasis, the investigators want to develop a classifier system that can

distinguish early MF from benign inflammatory skin diseases.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Clinical and/or histopathological diagnosis of MF, eczema or psoriasis

- Healthy control subjects without personal history of MF, eczema or psoriasis

Exclusion Criteria:

- Ongoing skin-targeted treatment (Wash out times: 2 weeks for topical, and 4 weeks for

systemic treatments)

- Ongoing other treatment that might, in the opinion of the investigator, influence

proteomic features of the samples to be acquired

Studien-Rationale

Primary outcome:

1. Proteomic signature of MF in comparison to eczema, psoriasis, and healthy control skin (Time Frame - At baseline):
Proteomic multiplex assay

Studien-Arme

Mycosis fungoides (MF)
Eczema (Atopic Dermatitis)
Chronic Plaque-Psoriasis
Healthy Control Skin

Geprüfte Regime

Skin suction blistering and skin biopsies:
Skin suction blistering and skin biopsies will be used for the identification of potential proteomic biomarkers that can distinguish MF from eczema, psoriasis and healthy control skin.

Quelle: ClinicalTrials.gov