Serum Protein Patterns in Participants With Mycosis Fungoides/Cutaneous T-Cell Lymphoma, Psoriasis, or Normal Skin
NCT ID: NCT00066664
Last Updated: 2012-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
423 participants
INTERVENTIONAL
2003-06-30
2010-03-31
Brief Summary
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PURPOSE: This clinical trial is studying how well blood protein analysis detects mycosis fungoides/cutaneous T-cell lymphoma.
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Detailed Description
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* 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.
Conditions
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Study Design
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DIAGNOSTIC
Interventions
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proteomic profiling
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
85 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
National Institutes of Health Clinical Center (CC)
NIH
Principal Investigators
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Mark C. Udey, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
NCI - Dermatology Branch
Locations
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Stanford Cancer Center
Stanford, California, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Countries
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References
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Liu C, Shea N, Rucker S, Harvey L, Russo P, Saul R, Lopez MF, Mikulskis A, Kuzdzal S, Golenko E, Fishman D, Vonderheid E, Booher S, Cowen EW, Hwang ST, Whiteley GR. Proteomic patterns for classification of ovarian cancer and CTCL serum samples utilizing peak pairs indicative of post-translational modifications. Proteomics. 2007 Nov;7(22):4045-52. doi: 10.1002/pmic.200601044.
Cowen EW, Liu CW, Steinberg SM, Kang S, Vonderheid EC, Kwak HS, Booher S, Petricoin EF, Liotta LA, Whiteley G, Hwang ST. Differentiation of tumour-stage mycosis fungoides, psoriasis vulgaris and normal controls in a pilot study using serum proteomic analysis. Br J Dermatol. 2007 Nov;157(5):946-53. doi: 10.1111/j.1365-2133.2007.08185.x. Epub 2007 Sep 13.
Other Identifiers
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03-C-0228
Identifier Type: -
Identifier Source: secondary_id
CDR0000316453
Identifier Type: -
Identifier Source: secondary_id
030228
Identifier Type: -
Identifier Source: org_study_id
NCT00063167
Identifier Type: -
Identifier Source: nct_alias
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