Characterization of Serum Proteomic Patterns in Neoplastic and Inflammatory Skin Disease
18 Years
85 Years
Both
Lymphoma
Trial Information
Characterization of Serum Proteomic Patterns in Neoplastic and Inflammatory Skin Disease
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.
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Diagnostic
Principal Investigator
Mark C. Udey, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
NCI - Dermatology Branch
Authority:
United States: Federal Government
Study ID:
030228
NCT ID:
NCT00066664
Start Date:
June 2003
Completion Date:
March 2010
Related Keywords:
- Lymphoma
- 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
- Lymphoma
- Mycosis Fungoides
- Lymphoma, T-Cell, Cutaneous
Name | Location |
|---|---|
| University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
| Stanford Cancer Center | Stanford, California 94305-5824 |
| Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Bethesda, Maryland 20892-1182 |
