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

Characterization of Serum Proteomic Patterns in Neoplastic and Inflammatory Skin Disease

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00066664

Enrollment

423

Registered

2003-08-07

Start date

2003-06-30

Completion date

2010-03-31

Last updated

2012-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma

Keywords

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

Brief summary

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

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.

Interventions

GENETICproteomic profiling

Study design

Primary purpose

DIAGNOSTIC

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Yes

Inclusion criteria

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026