Diagnostic Classifier for Cutaneous T-cell Lymphomas
1 other identifier
observational
160
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2020
CompletedFirst Posted
Study publicly available on registry
July 29, 2020
CompletedStudy Start
First participant enrolled
February 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 22, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedApril 5, 2022
April 1, 2022
2 years
July 23, 2020
April 4, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Proteomic signature of MF in comparison to eczema, psoriasis, and healthy control skin
Proteomic multiplex assay
At baseline
Study Arms (4)
Mycosis fungoides (MF)
Eczema (Atopic Dermatitis)
Chronic Plaque-Psoriasis
Healthy Control Skin
Interventions
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.
Eligibility Criteria
MF patients need prior histopathological verification of their disease. Eczema and psoriasis patients will be diagnosed clinically and, if necessary, on a histopathological basis.
You may qualify if:
- Clinical and/or histopathological diagnosis of MF, eczema or psoriasis
- Healthy control subjects without personal history of MF, eczema or psoriasis
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of Vienna
Vienna, 1090, Austria
Biospecimen
Suction blister fluid and skin biopsies.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 23, 2020
First Posted
July 29, 2020
Study Start
February 22, 2021
Primary Completion
February 22, 2023
Study Completion
June 30, 2024
Last Updated
April 5, 2022
Record last verified: 2022-04