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Characterizing Serum Protein Patterns in Selected Skin Diseases



Characterizing Serum Protein Patterns in Selected Skin Diseases

For Condition: Healthy,Cutaneous T-Cell Lymphoma,Psoriasis
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: The purpose of this study is to determine whether computer-aided analysis of proteins found in the blood can distinguish between the serum protein patterns in healthy patients versus patients with selected skin diseases, either psoriasis or cutaneous T cell lymphoma. It is hoped that the information obtained in this study will be useful in the development of improved methods for the diagnosis, prognosis, and treatment of diseases such as psoriasis and cutaneous T-cell lymphoma. Approximately 141 participants 18 years or older will be enrolled in this study, 47 for each of the study categories-healthy skin volunteers, patients with psoriasis, and patients with cutaneous T cell lymphoma. All participants will be examined by a dermatologist before being enrolled in the study. Each will fill out a questionnaire that details the participant's medical history and the general health of their skin. Investigators will then collect blood (20 cc) from each participant and analyze the serum for the presence of small proteins via a technique called mass spectroscopy. Participants enrolled through the Clinical Center of the National Institutes of Health for the express purposes of this protocol will be compensated $50 for their involvement in this study.
Details: The detection of low molecular weight serum proteins by mass spectroscopy and subsequent pattern analysis using software algorithms (i.e., artificial intelligence) represents a novel and potentially useful method by which to diagnose skin disease. This is a pilot study to determine whether serum proteomic patterns from healthy skin volunteers and patients with neoplastic and inflammatory skin disease are reproducibly different from each other and characteristic of specific skin diseases. Sera and non-linked data regarding the general health and skin disease history will be collected from healthy skin volunteers and patients with cutaneous T cell lymphoma and psoriasis for proteomic analysis.
Eligibility:
Study Type:  Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Age: 18-85 years For healthy skin volunteers: Willing to undergo brief skin examination and fill out questionnaire regarding skin and general health For patients with skin disease: Have either stable or worsening disease on no therapy or topical therapy only Must adhere to following disease-specific clinical criteria: For psoriasis patients: Have plaque-type psoriasis, Have a PASI score equal or greater than 12. For mycosis fungoides (CTCL) Patients: Have clinical diagnosis of T1-T4 skin disease with a compatible pathologic diagnosis. All patients must be able to understand and sign an informed consent. However, waivers of informed consent for the use of unlinked serum will be obtained for the use of previously banked serum and serum obtained from patients for other IRB-approved protocols . EXCLUSION CRITERIA: For normal skin control group: Individuals with significant inflammatory or neoplastic disease of the skin or internal organs as determined after physical examination and interview by a study investigator For patients with skin diseases: Individuals who have had systemic therapy for their skin disease in the 2 weeks prior to serum sampling Patients in whom disease has been improving in the 2 weeks prior to serum sampling For any patient with skin disease or healthy skin volunteer: Patients who have a known history of HIV-1 or HTLV-1 related diseases. Patients who are known to be pregnant by patient history.
Total Enrollment: 423

Location and Contact Information:

National Cancer Institute (NCI) *Recruiting*
Bethesda,  Maryland,  20892
United States
Recruiting Patient  and Public Liaison Office 1-800-411-1222


Additional Information:
Study ID Numbers:  030228;  03-C-0228
Study Start Date: June 19, 2003
Record last reviewed: June 9, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00063167

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