Evaluation of Patients Who Have Skin Diseases - Full Text View

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00019149

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)	Genetic: polymerase chain reaction Other: electron microscopy Other: flow cytometry Other: fluorescent antibody technique Other: immunoenzyme technique Other: immunohistochemistry staining method Other: microscopy Procedure: biopsy Procedure: radiography

Study Type:	Interventional
Study Design:	Diagnostic, Open Label
Official Title:	Evaluation and Treatment of Subjects With Dermatologic Diseases

Resource links provided by NLM:

MedlinePlus related topics: Fungal Infections Lymphoma Melanoma Skin Conditions

U.S. FDA Resources

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:

Primary

Determine the natural history of selected dermatologic or systemic diseases with cutaneous manifestations.
Provide clinical material to fulfill the educational mission of the Dermatology Branch.

Secondary

Screen patients for inclusion in other protocols.
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

Other

No concurrent investigational treatments

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

National Cancer Institute (NCI)

Investigators

Study Chair:

Mark C. Udey, MD, PhD

NCI - Dermatology Branch

More Information

Additional Information:

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

Publications:

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
Study First Received:	July 11, 2001
Last Updated:	February 11, 2009
ClinicalTrials.gov Identifier:	NCT00019149 History of Changes
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

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Nerve Tissue
Melanoma
Neuroendocrine Tumors
Lymphatic Diseases

Neuroectodermal Tumors
Neoplasms
Neoplasms, Germ Cell and Embryonal
Nevi and Melanomas
Lymphoproliferative Disorders
Lymphoma

ClinicalTrials.gov processed this record on November 09, 2009