Early Diagnosis of Mycosis Fungoides

NCT02539472 | Unknown

• 1 other identifier: K14097
• Study Type: interventional
• Target: 620
• Locations: 1 country
• Sites: 1

Brief Summary

Mycosis fungoides (MF) is an epidermotropic cutaneous T cell lymphoma characterized by the accumulation of CD4+ T-lymphocytes in the skin. Early MF presents as erythematous patches and/or infiltrated plaques. The diagnosis of early MF is a major diagnostic challenge and the differential diagnosis with inflammatory dermatoses is often very difficult. The histopathological diagnosis is also difficult and delayed. Therefore, it is important to develop biomarkers and/or a combination of biomarkers in order to improve the early diagnostic of MF. In a previous trial, investigators included 490 patients in a study aiming at identifying skin biomarkers of early MF. Several activating and inhibiting KIRs were found to be interesting for the skin diagnostic of MF, mainly KIR2DL4 and KIR3DL2. Investigators later evaluated blood biomarkers in patients with erythrodermic MF and Sezary Syndrome (SS). This French institutional study demonstrated that the identification by PCR of a combination of 4 blood markers (CD158k/KIR3DL2, PLS3/T-Plastin, Twist and NKp46) allowed a reliable diagnosis of lymphoma in erythrodermic patients. This previously published study interestingly showed that 30% to 50% of patients with early MF expressed at least one of these biomarkers in the blood (unpublished data). Other groups also recently showed that TOX can be a diagnostic tool for MF. The aim of this study is to establishing an accurate blood diagnosis for early suspected MF by demonstrating that newly identified biomarkers or their combination \[5 cutaneous KIR receptor markers (KIR2DS1, KIR2DS3, KIR3DL1, KIR2DL4, KIR3DL2) and 5 blood biomarkers (TOX, Twist-1, PLS3/T-plastin, KIR3DL2, NKp46)\] are differentially expressed by patients with MF and patients with inflammatory dermatoses closely resembling MF lesions. Statistical analysis will establish the best combination of blood biomarkers allowing the differentiation between the two groups of patients, combination that could represent a suitable diagnostic tool for early MF.

Conditions

Cutaneous T Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Early MF Benign inflammatory dermatoses

  12 months

Secondary Outcomes (1)

• Percentage of positivity of each marker

  12 months

Study Arms (1)

investigation

EXPERIMENTAL

Blood sampling for quantitative evaluation of nine candidate biomarkers (CD158k/KIR3DL2, KIR2DL4, KIR2DS1, KIR2DS3, KIR3DL1, NKp46, PLS3/T-Plastin, Twist and TOX) by quantitative RT-PCR.

Other: Blood sampling

Interventions

Blood sampling OTHER

Blood sampling for quantitative evaluation of nine candidate biomarkers (CD158k/KIR3DL2, KIR2DL4, KIR2DS1, KIR2DS3, KIR3DL1, NKp46, PLS3/T-Plastin, Twist and TOX) by quantitative RT-PCR.

investigation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with erythematous dermatitis of subacute evolution (\> 15 d) or chronic evolution, in the form of patches/plaques, leading to a clinically suspected cutaneous T cell lymphoma
• Free and informed consent signed
• Erythematous dermatosis, sub-acute (\> 15 days) or chronic, suspicious of MF
• Lack of previous hemopathy or cutaneous or extra-cutaneous lymphoma
• Age \> 18 years

You may not qualify if:

• Children under 18 years
• Sick adults under guardianship
• Patients refusing to participate in the research protocol
• Subjects not affiliated with the national health insurance system.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Saint Louis hospital

Paris, Paris, 75010, France

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell, Cutaneous

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Zakia IDIR

CONTACT

33144 84 17 47; zakia.idir@sls.aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2015
• First Posted: September 3, 2015
• Study Start: November 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: April 18, 2016

Record last verified: 2016-04

Locations

FR (1)