Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
620 participants
INTERVENTIONAL
2015-11-30
2017-11-30
Brief Summary
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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interestingly showed that 30% to 50% of patients with early MF expressed at least one of these biomarkers in the blood (unpublished data).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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Sick adults under guardianship
* Patients refusing to participate in the research protocol
* Subjects not affiliated with the national health insurance system.
18 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Locations
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Saint Louis hospital
Paris, Paris, France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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K14097
Identifier Type: -
Identifier Source: org_study_id
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