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

• Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00066664
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 423
• Locations: 4
• Duration (Months): 81
• Patients Per Site: 105.8
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Genetic: proteomic profiling	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 423 participants
• Primary Purpose: Diagnostic
• Official Title: Characterization of Serum Proteomic Patterns in Neoplastic and Inflammatory Skin Disease
• Study Start Date: Jun 1, 2003
• Actual Primary Completion Date: Dec 1, 2007
• Actual Study Completion Date: Mar 1, 2010

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford Cancer Center	Stanford	California	United States	94305-5824
2	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland	United States	21231-2410
3	Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office	Bethesda	Maryland	United States	20892-1182
4	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan	United States	48109-0942

Sponsors and Collaborators

• National Institutes of Health Clinical Center (CC)
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Mark C. Udey, MD, PhD, NCI - Dermatology Branch

Study Documents (Full-Text)

None provided.

More Information

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.

• ClinicalTrials.gov Identifier: NCT00066664
• Other Study ID Numbers: 030228; 03-C-0228; CDR0000316453; NCT00063167
• First Posted: Aug 7, 2003
• Last Update Posted: Mar 15, 2012
• Last Verified: Mar 1, 2012

• Keywords provided by , ,: recurrent cutaneous T-cell non-Hodgkin lymphoma; stage I cutaneous T-cell non-Hodgkin lymphoma; stage II cutaneous T-cell non-Hodgkin lymphoma; stage III cutaneous T-cell non-Hodgkin lymphoma; stage IV cutaneous T-cell non-Hodgkin lymphoma; recurrent mycosis fungoides/Sezary syndrome; stage I mycosis fungoides/Sezary syndrome; stage II mycosis fungoides/Sezary syndrome; stage III mycosis fungoides/Sezary syndrome; stage IV mycosis fungoides/Sezary syndrome
• Additional relevant MeSH terms: Mycoses; Lymphoma; Mycosis Fungoides

Study Results

No Results Posted as of Mar 15, 2012