Protocol Number: 03-C-0228

Title:

Characterization of Serum Proteomic Patterns in Neoplastic and Inflammatory Skin Disease

Number:

03-C-0228

Summary:

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.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility 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.

Special Instructions: Currently Not Provided

Keywords:

CTCL

Mycosis Fungoides

Psoriasis

Inflammation

Cancer

Recruitment Keywords:

Cutaneous T Cell Lymphoma

CTCL

Mycosis Fungoides

Psoriasis

Healthy Volunteer

HV

Conditions:

Psoriasis

Cutaneous T-Cell Lymphoma

Healthy

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:

Petricoin EF, Ardekani AM, Hitt BA, Levine PJ, Fusaro VA, Steinberg SM, Mills GB, Simone C, Fishman DA, Kohn EC, Liotta LA. Use of proteomic patterns in serum to identify ovarian cancer. Lancet. 2002 Feb 16;359(9306):572-7. PMID: 11867112

Zackheim HS, Amin S, Kashani-Sabet M, McMillan A. Prognosis in cutaneous T-cell lymphoma by skin stage: long-term survival in 489 patients. J Am Acad Dermatol. 1999 Mar;40(3):418-25. PMID: 10071312

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

Search The Studies | Help | Questions |
Clinical Center Home | NIH Home

Warren Grant Magnuson Clinical Center (CC)
National Institutes of Health (NIH)
Bethesda, Maryland 20892. Last update: 10/19/2004