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

Not Applicable

Completed

• Conditions: Lymphoma

• Registration Number: NCT00066664
• Lead Sponsor: National Institutes of Health Clinical Center (CC)

Brief Summary

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.

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 Timeline

• Study Start: 2003-06
• Study First Submitted: 2003-08-06
• Study First Submitted QC: 2003-08-06
• Study First Posted: 2003-08-07
• Primary Completion: 2007-12
• Study Completion: 2010-03
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-14
• Last Update Posted: 2012-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 423

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (4)

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