- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00066664
Serum Protein Patterns in Participants With Mycosis Fungoides/Cutaneous T-Cell Lymphoma, Psoriasis, or Normal Skin
Characterization of Serum Proteomic Patterns in Neoplastic and Inflammatory Skin Disease
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.
Study Overview
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Stanford, California, United States, 94305-5824
- Stanford Cancer Center
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Maryland
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Baltimore, Maryland, United States, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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Bethesda, Maryland, United States, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
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Michigan
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Ann Arbor, Michigan, United States, 48109-0942
- University of Michigan Comprehensive Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Mark C. Udey, MD, PhD, NCI - Dermatology Branch
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- stage I cutaneous T-cell non-Hodgkin lymphoma
- stage I mycosis fungoides/Sezary syndrome
- stage III cutaneous T-cell non-Hodgkin lymphoma
- stage IV cutaneous T-cell non-Hodgkin lymphoma
- recurrent cutaneous T-cell non-Hodgkin lymphoma
- stage III mycosis fungoides/Sezary syndrome
- stage IV mycosis fungoides/Sezary syndrome
- recurrent mycosis fungoides/Sezary syndrome
- stage II cutaneous T-cell non-Hodgkin lymphoma
- stage II mycosis fungoides/Sezary syndrome
Additional Relevant MeSH Terms
Other Study ID Numbers
- 030228
- 03-C-0228
- CDR0000316453
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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