RATIONALE: The presence of specific serum proteins may allow a doctor to determine if a patient has mycosis fungoides/cutaneous T-cell lymphoma.

PURPOSE: Pilot study to evaluate the effectiveness of analyzing blood proteins in detecting mycosis fungoides/cutaneous T-cell lymphoma.

Condition	Treatment or Intervention
Cutaneous T-Cell Lymphoma mycosis fungoides and Sezary syndrome	Procedure: diagnostic test  Procedure: proteomic profiling

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.

Ages Eligible for Study:  18 Years   -   85 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

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

Maryland
      Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore,  Maryland,  21231,  United States; Recruiting
      Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda,  Maryland,  20892-1182,  United States; Recruiting
Michigan
      University of Michigan Comprehensive Cancer Center, Ann Arbor,  Michigan,  48109-0314,  United States; Recruiting

Study chairs or principal investigators

Sam T. Hwang, MD, PhD,  Principal Investigator,  NCI - Dermatology Branch   

Study ID Numbers:  CDR0000316453; NCI-03-C-0228
Record last reviewed:  July 2003
Record first received:  August 6, 2003
ClinicalTrials.gov Identifier:  NCT00066664
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-18