Evaluation of Patients Who Have Skin Diseases - Tabular View

Tracking Information

First Received Date ^ICMJE

July 11, 2001

Last Updated Date

February 11, 2009

Start Date ^ICMJE

June 1996

Estimated Primary Completion Date

December 2016 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Provide clinical material to fulfill the educational mission of the Dermatology Branch
Natural history of selected dermatologic diseases

Change History

Complete list of historical versions of study NCT00019149 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Screen patients for inclusion in other protocols
Diagnosis and/or management of patients with rare skin diseases

Descriptive Information

Brief Title ^ICMJE

Evaluation of Patients Who Have Skin Diseases

Official Title ^ICMJE

Evaluation and Treatment of Subjects With Dermatologic Diseases

Brief Summary

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.

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic, Open Label

Condition ^ICMJE

Lymphoma
Melanoma (Skin)

Intervention ^ICMJE

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 Arms / Comparison Groups

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

500

Completion Date

Estimated Primary Completion Date

December 2016 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00019149

Responsible Party

Study ID Numbers ^ICMJE

CDR0000064802, NCI-96-C-0102

Study Sponsor ^ICMJE

National Cancer Institute (NCI)

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Mark C. Udey, MD, PhD

NCI - Dermatology Branch

Information Provided By

National Cancer Institute (NCI)

Verification Date

April 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP