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



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

For Condition: mycosis fungoides and Sezary syndrome,Cutaneous T-Cell Lymphoma
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: RATIONALE: The presence of specific serumproteins 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.
Details: 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.
Eligibility:
Study Type:
  Interventional, Diagnostic
Minimum Age/Maximum Age: 18 Years/85 Years
Genders: Both
Protocol 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 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
SamHwang,  Principal Investigator,  Dermatology Branch

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda,  Maryland,  20892-1182
United States
Recruiting Patient  Recruitment 888-NCI-1937

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore,  Maryland,  21231
United States
Recruiting Eric  Vonderheid 410-955-5000

University of Michigan Comprehensive Cancer Center *Recruiting*
Ann Arbor,  Michigan,  48109-0752
United States
Recruiting Sewon  Kang 734-936-4192


Additional Information:
Study ID Numbers:
  CDR0000316453;  NCI-03-C-0228
Study Start Date: 
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00066664

Other Mycosis Fungoides And Sezary Syndrome Studies:
1. Pegfilgrastim Compared With Filgrastim To Increase Peripheral Stem Cells Before Autologous Stem Cell Transplantation in Treating Patients With Lymphoma

2. FR901228 in Treating Patients With T-Cell Lymphoma

3. Chemotherapy and Radiation Therapy Plus Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory T-cell Lymphoma, Hodgkin's Lymphoma, or Non-Hodgkin's Lymphoma

4. Temozolomide in Treating Patients With Mycosis Fungoides or Sezary Syndrome

5. Clinical Trial of HuMax-CD4, a new drug to treat Early Stage T-Cell Lymphoma in the skin.

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

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