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OpenTrials
Completed

NCT Number: NCT00066664

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

RATIONALE: The presence of specific serum proteins may allow a doctor to determine if a patient has mycosis fungoides/cutaneous T-cell lymphoma.

PURPOSE: This clinical trial is studying how well blood protein analysis detects mycosis fungoides/cutaneous T-cell lymphoma.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford Cancer Center, Stanford, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

proteomic profiling

Genetic

Sponsors and collaborators

Lead sponsor

National Institutes of Health Clinical Center (CC)

Nih

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Characterization of Serum Proteomic Patterns in Neoplastic and Inflammatory Skin Disease

Important dates

Study start
2003
Primary completion
2007
Study completion
2010
First posted
Aug 7, 2003
Registry last updated
Mar 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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