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Characterization of Serum Proteomic Patterns in Neoplastic and Inflammatory Skin Disease


N/A
18 Years
85 Years
Not Enrolling
Both
Lymphoma

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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 CenterAnn Arbor, Michigan  48109-0752
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Stanford Cancer CenterStanford, California  94305-5824
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral OfficeBethesda, Maryland  20892-1182