Dermatitis Clinical Trial
Official title:
Analysis of Killer Immunoglobulin-like Receptor Transcripts Expression for the Diagnosis of Epidermotropic Cutaneous T-cell Lymphomas (Mycosis Fungoid and Sézary Syndrome) in Patients With Erythroderma or Erythematous Patches/Plaques.
The most frequent cutaneous T-cell lymphomas (CTCL) are mycosis fungoid and Sezary syndrome. The diagnosis of these lymphomas is difficult using current methods, especially because numerous benign dermatological conditions can mimick CTCL both clinically and under microscopic examination. Recently, the KIR receptor CD158k has been shown to be a marker for Sezary syndrome in both the blood and skin. We hypothesize that other receptors from the same family may help fro the diagnosis of these lymphomas. To address this issue, we will study the expression of all known KIR receptor in the skin of patients presenting with a skin eruption, which may correspond to either a cutaneous T-cell lymphoma or a benign dermatological disease. The final diagnosis will be established by a panel of experts, allowing constitution of 2 groups of patients : the cutaneous T-cell lymphoma group, and the benign inflammatory disease group. The expression of the different KIRs will be analyzed in both group in a blinded fashion, in order to determine whether one or a several KIRs may be differentially expressed.
Background : The most frequent cutaneous T-cell lymphomas (CTCL) are mycosis fungoid and
Sezary syndrome. Both are due to the proliferation of a CD4+ T-cell clone in the skin,
associated with a blood involvement in Sezary syndrome. Mycosis fungoid clinically presents
as a patches or plaques dermatitis and Sezary syndrome as an exfoliative dermatitis. The
diagnosis of these lymphomas is difficult using current methods, especially because numerous
benign dermatological inflammatory conditions can mimick CTCL both clinically and under
microscopic examination. Recently, the KIR receptor CD158k has been shown to be a marker for
Sezary syndrome in both the blood and skin. We hypothesize that other receptors from the
same family may help fro the diagnosis of these lymphomas.
Aim of the study : to determine if one or a panel of KIR(s) receptor(s) may help for the
differential diagnosis between cutaneous T-cell lymphoma (CTCL) and benign inflammatory
dermatoses.
Subjects selection : all patients presenting to an investigator, member of the GFELC experts
group ("French Group Study Cutaneous Lymphoma"), with either an exfoliative or patch/plaque
dermatitis with a clinical suspicion of CTCL will be enrolled.
Number of subjects : A total of 550 patients could be recruited by the GFELC, including 180
CTCL (60 Sezary syndrome and 120 mycosis fungoid) and 370 inflammatory diseases (240 patch
dermatitis and 130 exfoliative dermatitis).
Inclusion period : patients will be included during a 2 years period and will be followed
during 6 months. Total study length will be 30 months.
Interventions : 1) 3 mm punch skin biopsy for all patients 2) 10 ml blood sample for
patients with exfoliative dermatitis Methods : Following initial and 6 month follow-up
evaluations, patients will be classified in one of the following groups : the cutaneous
T-cell lymphoma group, and the benign inflammatory disease group. The expression of all
known KIRs receptors (KIR2DL1 (CD158a), KIR2DL2 (CD158b1), KIR2DL3 (CD158b2), KIR2DL4
(CD158d), KIR2DL5 (CD158f), KIR3DL1 (CD158e1), KIR3DL2 (CD158k), KIR2DS1 (CD158h), KIR2DS2
(CD158j), KIR2DS4 (CD158i), KIR2DS5 (CD158g), KIR3DS1 (CD158e2)) will be evaluated using
reverse transcription and quantitative polymerase chain reaction in all skin and blood
samples, in a blinded fashion. For blood samples, the analyses will be performed on CD4+
T-cell sorted using magnetic beads.
Outcome measures : The main outcome measure will be the differential expression of one or a
panel of KIR(s) receptor(s) between CTCL and benign inflammatory diseases. Secondary outcome
measure will be a differential quantitative expression of one or a panel of KIR(s)
receptor(s) between the two groups.
;
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03563066 -
Effect of Benralizumab in Atopic Dermatitis
|
Phase 2 | |
Completed |
NCT02916888 -
A Study Comparing the Quality of Life of Patients in the Treatment of Eczema by Pediatric Generalists and Specialists
|
N/A | |
Recruiting |
NCT01631617 -
Effects of Treatments on Atopic Dermatitis
|
Phase 2 | |
Completed |
NCT03720470 -
Study Evaluating Efficacy and Safety of PF-04965842 and Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis on Background Topical Therapy
|
Phase 3 | |
Recruiting |
NCT01012453 -
A Randomised Clinical Trial in a Population of Health Care Workers With Hand Eczema
|
N/A | |
Completed |
NCT00375713 -
Randomized Phase III Study to Evaluate the Efficacy and Safety of Xyzal® (Levocetirizine) vs Zyrtec® (Cetirizine) in Subjects With Dermatitis and Eczema
|
Phase 3 | |
Completed |
NCT00001150 -
Induction of Suction Blisters in Patients With Urticaria, Blistering Diseases, Inflammatory Dermatoses and Neoplastic Disorders, and in Normal Volunteers
|
N/A | |
Completed |
NCT05247333 -
Implementation of a Minor Ailment Service in Community Pharmacy Practice
|
N/A | |
Withdrawn |
NCT04154033 -
Treatment of Chronic Itch in Atopic Dermatitis With Topical Naltrexone
|
Phase 2 | |
Completed |
NCT02979210 -
Infant Fecal Insult Study
|
N/A | |
Completed |
NCT02615912 -
A Single-Center, Exploratory Study to Analyze the Dynamics of Skin Microflora Following Exposure to Surfactants
|
N/A | |
Withdrawn |
NCT01125761 -
Efficacy and Safety of the Association Drugs in Patients With Allergic Dermatitis
|
Phase 3 | |
Withdrawn |
NCT00746382 -
A Placebo Controlled 4 Week Proof of Concept Study With 0.5% Roflumilast Cream in Patients With Mild Atopic Dermatitis (RO-2351-001-EM)
|
Phase 2 | |
Terminated |
NCT00176956 -
Atopic Dermatitis-Like Skin Disease in Pediatric Heart Transplant Patients
|
Phase 3 | |
Completed |
NCT05001139 -
Clinical Investigation on the Efficacy and Safety of Relizema Ecofoam
|
N/A | |
Completed |
NCT00801502 -
Salmon in Pregnancy Study
|
N/A | |
Completed |
NCT00005781 -
Assessment of Digital Imaging as a Tool for Diagnosing Psoriasis, Hand Rashes and Unusual Moles
|
N/A | |
Completed |
NCT05324618 -
Tacrolimus Versus Hydrocortisone in Atopic Dermatitis
|
Phase 4 | |
Completed |
NCT04826471 -
Clinical Investigation on the Performance and Safety of DermoRelizema Ecofoam
|
N/A | |
Recruiting |
NCT06436183 -
A Study of the Effects of Camoteskimab in Adults With Moderate to Severe Atopic Dermatitis
|
Phase 2 |