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Diagnostic Classifier for Cutaneous T-cell Lymphomas

Diagnostic Classifier for Cutaneous T-cell Lymphomas

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04491825
Enrollment
160
Registered
2020-07-29
Start date
2021-02-22
Completion date
2024-06-30
Last updated
2022-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CTCL/ Mycosis Fungoides

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.

Interventions

DIAGNOSTIC_TESTSkin 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.

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Proteomic signature of MF in comparison to eczema, psoriasis, and healthy control skinAt baselineProteomic multiplex assay

Countries

Austria

Contacts

Primary ContactPatrick M Brunner, MD, MSc
patrick.brunner@meduniwien.ac.at+43140400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026