Diagnostic Classifier for Cutaneous T-cell Lymphomas

NCT ID: NCT04491825

Last Updated: 2022-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-22

Study Completion Date

2024-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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CTCL/ Mycosis Fungoides

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Mycosis fungoides (MF)

Skin suction blistering and skin biopsies

Intervention Type DIAGNOSTIC_TEST

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.

Eczema (Atopic Dermatitis)

Skin suction blistering and skin biopsies

Intervention Type DIAGNOSTIC_TEST

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.

Chronic Plaque-Psoriasis

Skin suction blistering and skin biopsies

Intervention Type DIAGNOSTIC_TEST

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.

Healthy Control Skin

Skin suction blistering and skin biopsies

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Patrick M. Brunner

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Medical University of Vienna

Vienna, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Patrick M Brunner, MD, MSc

Role: CONTACT

+43140400 ext. 77020

Facility Contacts

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Patrick Brunner, MD, MSc

Role: primary

+436644605954

Other Identifiers

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CTCL_Classifier_KLIF

Identifier Type: -

Identifier Source: org_study_id

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