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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Notify MeKey information
Conditions
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
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
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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