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Early Diagnosis of Mycosis Fungoides (DIAPREMYF)

Primary Purpose

Cutaneous T Cell Lymphoma

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sampling
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cutaneous T Cell Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Saint Louis hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

investigation

Arm Description

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.

Outcomes

Primary Outcome Measures

Early MF Benign inflammatory dermatoses

Secondary Outcome Measures

Percentage of positivity of each marker
[5 cutaneous KIR receptor markers (KIR2DS1, KIR2DS3, KIR3DL1, KIR2DL4, KIR3DL2) and 5 blood biomarkers (TOX, Twist-1, PLS3/T-plastin, KIR3DL2, NKp46)]

Full Information

First Posted
July 20, 2015
Last Updated
April 15, 2016
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02539472
Brief Title
Early Diagnosis of Mycosis Fungoides
Acronym
DIAPREMYF
Official Title
Evaluation of a Combination of Blood Biomarkers for the Early Diagnosis of Mycosis Fungoides
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
November 2017 (Anticipated)
Study Completion Date
November 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous T Cell Lymphoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
620 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
investigation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Blood sampling
Intervention Description
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 Measure Information:
Title
Early MF Benign inflammatory dermatoses
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Percentage of positivity of each marker
Description
[5 cutaneous KIR receptor markers (KIR2DS1, KIR2DS3, KIR3DL1, KIR2DL4, KIR3DL2) and 5 blood biomarkers (TOX, Twist-1, PLS3/T-plastin, KIR3DL2, NKp46)]
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zakia IDIR
Phone
33144 84 17 47
Email
zakia.idir@sls.aphp.fr
Facility Information:
Facility Name
Saint Louis hospital
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martine Bagot, MDPhD
Phone
33 1 42494949
Email
martine.bagot@aphp.fr

12. IPD Sharing Statement

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Early Diagnosis of Mycosis Fungoides

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