Evaluation of Patients Who Have Skin Diseases - Full Text View

Purpose

RATIONALE: Evaluating patients who have skin diseases may help doctors plan more effective treatment and follow-up for skin diseases and systemic diseases that show up in the skin.

PURPOSE: This clinical trial is studying and following patients with skin diseases.

Condition	Intervention
Lymphoma Melanoma (Skin)	Procedure: biopsy Procedure: electron microscopy Procedure: flow cytometry Procedure: fluorescent antibody technique Procedure: immunoenzyme technique Procedure: immunohistochemistry staining method Procedure: microscopy Procedure: polymerase chain reaction Procedure: radiography

MedlinePlus related topics:

Fungal Infections Lymphoma Melanoma Skin Conditions

Drug Information available for:

X-Rays

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label

Official Title:	Evaluation and Treatment of Subjects With Dermatologic Diseases

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

Primary Outcome Measures:

Provide clinical material to fulfill the educational mission of the Dermatology Branch [ Designated as safety issue: No ]
Natural history of selected dermatologic diseases [ Designated as safety issue: No ]

Secondary Outcome Measures:

Screen patients for inclusion in other protocols [ Designated as safety issue: No ]
Diagnosis and/or management of patients with rare skin diseases [ Designated as safety issue: No ]

Estimated Enrollment:	500
Study Start Date:	June 1996
Estimated Primary Completion Date:	December 2016 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Determine the natural history of selected dermatologic or systemic diseases with cutaneous manifestations.
Assist the treating physicians with determining the diagnosis and appropriate medical or surgical therapy for patients with rare skin diseases.

OUTLINE: Samples of blood, urine, stool, exudates, skin scrapings, hair, and nails are collected from patients and then are analyzed, as medically indicated, using the following diagnostic tests:

Chemistry
Serology
Pregnancy testing
Cultures
Cytology
Microscopic examination for fungi, bacteria, and parasites
Immunopathologic tests, including:
- Direct and indirect immunofluorescence microscopy
- Direct and indirect immunoelectron microscopy
- Characterization of circulating autoantibodies by immunoprecipitation and/or immunoblotting
HIV testing
Electrocardiogram
Diagnostic x-ray and other imaging procedures
Patch testing
Photography, including infrared photography
Skin biopsies (punch, shave or tangential, and excisional)
Fluorescent-activated cell sorter
Polymerase chain reaction for infectious agents
Immunohistochemistry
Special stains Patients also undergo consultation with other services, as medically indicated. Diagnostic test results are used to assist the treating physicians with determining the diagnosis and appropriate medical or surgical therapy. Patients also may participate in clinical medical conferences.

PROJECTED ACCRUAL: A total of 500 patients will be accrued for this study.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Dermatologic or systemic disease with cutaneous manifestations requiring determination of a diagnosis and appropriate medical or surgical therapy
Physician referral required
No cognitive impairment

PATIENT CHARACTERISTICS:

Age:

Any age

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Not specified

Renal:

Not specified

Other:

Pregnant, nursing, or fertile women eligible unless status would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy

Not specified

Chemotherapy

Not specified

Endocrine therapy

Not specified

Radiotherapy

Not specified

Surgery

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00019149

Locations


United States, Maryland
	Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office	Recruiting
	Bethesda, Maryland, United States, 20892-1182
	Contact: Patient Recruitment 888-NCI-1937

Sponsors and Collaborators

NCI - Center for Cancer Research-Medical Oncology

National Cancer Institute (NCI)

Investigators


Study Chair:	Mark C. Udey, 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:

Luke MC, Darling TN, Hsu R, Summers RM, Smith JA, Solomon BI, Thomas GR, Yancey KB. Mucosal morbidity in patients with epidermolysis bullosa acquisita. Arch Dermatol. 1999 Aug;135(8):954-9.

Study ID Numbers:	CDR0000064802, NCI-96-C-0102
First Received:	July 11, 2001
Last Updated:	October 18, 2008
ClinicalTrials.gov Identifier:	NCT00019149
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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

stage I melanoma

stage II melanoma

stage III melanoma

stage IV melanoma

stage 0 melanoma

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

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Mycoses

Lymphatic Diseases

Antibodies

Nevus, Pigmented

Neoplasms, Germ Cell and Embryonal

Lymphoma, T-Cell

Neuroepithelioma

Nevus

Lymphoma, Non-Hodgkin

Lymphoproliferative Disorders

Lymphoma

Lymphoma, T-Cell, Cutaneous

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Immune System Diseases

Neoplasms, Nerve Tissue

Nevi and Melanomas

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:	NCT00019149