Serum Protein Patterns in Participants With Mycosis Fungoides/Cutaneous T-Cell Lymphoma, Psoriasis, or Normal Skin
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|ClinicalTrials.gov Identifier: NCT00066664|
Recruitment Status : Completed
First Posted : August 7, 2003
Last Update Posted : March 15, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Genetic: proteomic profiling||Not Applicable|
- 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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||423 participants|
|Official Title:||Characterization of Serum Proteomic Patterns in Neoplastic and Inflammatory Skin Disease|
|Study Start Date :||June 2003|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||March 2010|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00066664
|United States, California|
|Stanford Cancer Center|
|Stanford, California, United States, 94305-5824|
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office|
|Bethesda, Maryland, United States, 20892-1182|
|United States, Michigan|
|University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109-0942|
|Principal Investigator:||Mark C. Udey, MD, PhD||NCI - Dermatology Branch|