Serum Protein Patterns in Participants With Mycosis Fungoides/Cutaneous T-Cell Lymphoma, Psoriasis, or Normal Skin

Study Overview
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Brief Summary
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RATIONALE: The presence of specific serum proteins may allow a doctor to determine if a patient has mycosis fungoides/cutaneous T-cell lymphoma. PURPOSE: This clinical trial is studying how well blood protein analysis detects mycosis fungoides/cutaneous T-cell lymphoma.

Detailed Description
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OBJECTIVES: Determine whether computer-assisted, higher-order analysis of participant low molecular weight serum proteins can detect distinctive proteomic patterns in participants with normal skin vs mycosis fungoides/cutaneous T-cell lymphoma vs psoriasis. Determine whether these proteomic patterns can distinguish between various stages of cutaneous T-cell lymphoma. OUTLINE: This is a pilot study. Participants complete a general and skin health questionnaire and undergo a whole-body skin examination. Blood samples are taken and analyzed for low molecular weight serum proteins by mass spectroscopy. PROJECTED ACCRUAL: A total of 141-423 participants (47-94 each of healthy volunteers, psoriasis patients, and T3 cutaneous T-cell lymphoma patients and 141 T1, T2, and T4 mycosis fungoides patients) will be accrued for this study within 3 years.

Official Title
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Characterization of Serum Proteomic Patterns in Neoplastic and Inflammatory Skin Disease

Conditions
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Lymphoma

Intervention / Treatment
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* Genetic: proteomic profiling


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Meets criteria for 1 of the following categories: Healthy skin volunteer No significant inflammatory or neoplastic disease of the skin or internal organs Diagnosis of 1 of the following skin diseases*: Psoriasis Plaque-type disease Psoriasis Area and Severity Index score at least 12 Mycosis fungoides/cutaneous T-cell lymphoma Clinical diagnosis of T1-T4 skin disease with a compatible pathologic diagnosis NOTE: *Stable or worsening disease on no therapy or topical therapy only within the past 2 weeks PATIENT CHARACTERISTICS: Age 18 to 85 Performance status Not specified Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Other Not pregnant No known HIV-1-related diseases No known HTLV-1-related diseases Willing to undergo brief skin examination and fill out a questionnaire regarding skin and general health PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified Other More than 2 weeks since prior systemic therapy for skin disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic


Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: proteomic profiling|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent cutaneous T-cell non-Hodgkin lymphoma, stage I cutaneous T-cell non-Hodgkin lymphoma, stage II cutaneous T-cell non-Hodgkin lymphoma, stage III cutaneous T-cell non-Hodgkin lymphoma, stage IV cutaneous T-cell non-Hodgkin lymphoma, recurrent mycosis fungoides/Sezary syndrome, stage I mycosis fungoides/Sezary syndrome, stage II mycosis fungoides/Sezary syndrome, stage III mycosis fungoides/Sezary syndrome, stage IV mycosis fungoides/Sezary syndrome