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Early Diagnosis of Mycosis Fungoides (DIAPREMYF)

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ClinicalTrials.gov Identifier: NCT02539472
Recruitment Status : Unknown
Verified April 2016 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Recruiting
First Posted : September 3, 2015
Last Update Posted : April 18, 2016
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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interestingly showed that 30% to 50% of patients with early MF expressed at least one of these biomarkers in the blood (unpublished data).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.


Condition or disease Intervention/treatment Phase
Cutaneous T Cell Lymphoma Other: Blood sampling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 620 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of a Combination of Blood Biomarkers for the Early Diagnosis of Mycosis Fungoides
Study Start Date : November 2015
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : November 2017


Arm Intervention/treatment
Experimental: investigation
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
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.




Primary Outcome Measures :
  1. Early MF Benign inflammatory dermatoses [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Percentage of positivity of each marker [ Time Frame: 12 months ]
    [5 cutaneous KIR receptor markers (KIR2DS1, KIR2DS3, KIR3DL1, KIR2DL4, KIR3DL2) and 5 blood biomarkers (TOX, Twist-1, PLS3/T-plastin, KIR3DL2, NKp46)]



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • A skin biopsy for routine diagnostic histopathological analysis at the time of inclusion
  • With an analysis of T-cell clonality in blood and skin at the time of inclusion

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02539472


Contacts
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Contact: Zakia IDIR 33144 84 17 47 zakia.idir@sls.aphp.fr

Locations
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France
Saint Louis hospital Recruiting
Paris, France, 75010
Contact: Martine Bagot, MDPhD    33 1 42494949    martine.bagot@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02539472     History of Changes
Other Study ID Numbers: K14097
First Posted: September 3, 2015    Key Record Dates
Last Update Posted: April 18, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
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Lymphoma, T-Cell
Mycoses
Mycosis Fungoides
Lymphoma, T-Cell, Cutaneous
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases