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

Purpose

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	Intervention
Lymphoma	Procedure: proteomic profiling

MedlinePlus related topics:

Cancer Fungal Infections Lymphoma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic

Official Title:	Characterization of Serum Proteomic Patterns in Neoplastic and Inflammatory Skin Disease

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	423
Study Start Date:	June 2003
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00066664

Locations


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

Sponsors and Collaborators

NCI - Center for Cancer Research-Medical Oncology

National Cancer Institute (NCI)

Investigators


Principal Investigator:	Sam T. Hwang, MD, PhD	NCI - Dermatology Branch

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications of Results:

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. Epub 2007 Sep 13.

Other 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.

Study ID Numbers:	CDR0000316453, NCI-03-C-0228
First Received:	August 6, 2003
Last Updated:	October 18, 2008
ClinicalTrials.gov Identifier:	NCT00066664
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Sezary syndrome

Immunoproliferative Disorders

Skin Diseases

Cutaneous T-cell lymphoma

Lymphoma, small cleaved-cell, diffuse

Sezary Syndrome

Mycosis Fungoides

Recurrence

Mycoses

Lymphatic Diseases

Psoriasis

Lymphoma, T-Cell

Lymphoma, Non-Hodgkin

Lymphoproliferative Disorders

Lymphoma

Lymphoma, T-Cell, Cutaneous

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Immune System Diseases

ClinicalTrials.gov processed this record on November 30, 2008

Sponsors and Collaborators:	NCI - Center for Cancer Research-Medical Oncology National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00066664