Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Diagnostic	Completed	18 to 85	NCI	NCI-03-C-0228 NCT00066664

Objectives

1. 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.
2. Determine whether these proteomic patterns can distinguish between various stages of cutaneous T-cell lymphoma.

Entry 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]

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

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

Expected Enrollment

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.

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.

Cowen EW, Liu CW, Steinberg SM, et al.: Differentiation of tumour-stage mycosis fungoides, psoriasis vulgaris and normal controls in a pilot study using serum proteomic analysis. Br J Dermatol 157 (5): 946-53, 2007.[PUBMED Abstract]

Liu C, Shea N, Rucker S, et al.: Proteomic patterns for classification of ovarian cancer and CTCL serum samples utilizing peak pairs indicative of post-translational modifications. Proteomics 7 (22): 4045-52, 2007.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Mark Udey, MD, PhD, Principal investigator		Ph: 301-496-2481

Registry Information
Official Title		Characterization of Serum Proteomic Patterns in Neoplastic and Inflammatory Skin Disease
Trial Start Date		2003-06-27
Trial Completion Date		2007-12-31
Registered in ClinicalTrials.gov		NCT00066664
Date Submitted to PDQ		2003-06-27
Information Last Verified		2007-12-10

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