Killer Immunoglobulin-Like Receptor Transcripts Expression for the Diagnosis of Epidermotropic Cutaneous T Cell Lymphoma

Dermatitis Clinical Trial

— KIR  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00748319
• Other study ID #: P070153
• Status: Completed
• Phase: N/A
• First received: September 5, 2008
• Last updated: August 21, 2012
• Start date: March 2009
• Est. completion date: December 2011

Study information

• Verified date: August 2012
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 495
• Est. completion date: December 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

• Signed consent

• Subacute/chronic dermatitis (>7 days) with clinical suspicion for cutaneous T-cell lymphoma

• No past history of lymphoma or other hematologic malignancy

• Skin biopsy for routine histology at inclusion

• Cutaneous T-cell clonality analysis at inclusion

• Sezary cell count on routine blood smear examination in case of erythroderma

• Blood T-cell clonality analysis at inclusion in case of erythroderma

• Age<18 years

• Skin biopsy for routine histology at inclusion (Possibility, in the 6 previous months of inclusion without any specific treatment other taht local corticoids- amendment n°4)

• Cutaneous T-cell clonality analysis at inclusion (Possibility, in the 6 previous months of inclusion without any specific treatment other taht local corticoids- amendment n°4)

• Realization of a preliminary medical examination

• Sezary cell count on routine blood smear examination in case of erythroderma (Possibility, in the 6 previous months of inclusion without any specific treatment other taht local corticoids- amendment n°4)

• Blood T-cell clonality analysis at inclusion in case of erythroderma (Possibility, in the 6 previous months of inclusion without any specific treatment other taht local corticoids- amendment n°4)

Exclusion Criteria:

• Adults under tutelage

• Subject not affiliated at the French National health and pensions organization

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Exfoliative
• Eczema
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous
• Mycoses
• Mycosis Fungicides
• Sezary Syndrome

Intervention

Other:
• Detection of KIR receptor by RT PCR
Detection on biopsy cutaneous (3mm) and on blood sample of 30 ml

Locations

Country	Name	City	State
France	Groupe hospitalier Henri Mondor - Albert Chenevier	Creteil

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differential expression of one or a panel of KIRs transcript(s) between epidermotropic cutaneous lymphoma and inflammatory diseases		at the inclusion	Yes
Secondary	Difference(s) in the quantitative expression of one or a panel of KIRs transcript(s) between epidermotropic cutaneous lymphoma and inflammatory diseases		at the inclusion	Yes