Viewing Study NCT00341809



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Last Modification Date: 2024-10-26 @ 9:25 AM
Study NCT ID: NCT00341809
Status: COMPLETED
Last Update Posted: 2018-04-05
First Post: 2006-06-19

Brief Title: Genetic Analysis of Psoriasis and Psoriatic Arthritis
Sponsor: National Cancer Institute NCI
Organization: National Institutes of Health Clinical Center CC

Study Overview

Official Title: Role of HLA and KIR in the Natural History of Psoriasis
Status: COMPLETED
Status Verified Date: 2012-09-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This study will examine the genetic basis of psoriasis and psoriatic arthritis It is known that genes play an important role in determining who gets psoriasis or psoriatic arthritis This study will look for specific gene variants alleles that run in families with these conditions or are found more often in people with these conditions than in those without them

Participants for this study were identified through the dermatology services of the University of Michigan Medical Center the Ann Arbor Veterans Affairs Medical Center the University of Kiel and Henry Ford Hospital Additional families were provided by the National Psoriasis Foundation Tissue Bank They include people with psoriasis or psoriatic arthritis or both in addition to some family members of patients Only families in which the age of the patient at disease onset was below 40 years are included Patients were included if they had lesions covering more than 1 percent of their total body surface area or if at least two skin scalp nail or joint lesions were diagnosed as psoriasis Healthy volunteers are also enrolled as control subjects

Participants undergo the following procedures as follows

Patients with psoriasis and people without psoriasis who have multiple family members with the disease

Skin evaluation
Photographs of lesions for documentation

Patients with psoriatic arthritis and people without psoriatic arthritis who have multiple family members with the disease

Joint evaluation and possibly ultrasound
Joint X-rays or review of existing X-rays

Patients with psoriasis only with psoriatic arthritis and healthy volunteers

Blood draw of 30 milliliters Some of the blood collected will be used to test for rheumatoid factor and C-reactive protein in patients with psoriatic arthritis
Periodic questionnaires to update health status information
Detailed Description: The aim of the study is to examine the role of HLA and killer immunoglobulin-like receptors KIR in the natural history of psoriasis vulgaris Psoriasis is a chronic inflammatory disease of the skin with features of an autoimmune disease and previous studies have revealed an association with certain HLA class I alleles notably HLA-Cw0602 Natural Killer NK cells are a unique group of lymphocytes involved in surveillance of killing of foreign or infected cells through a mechanism involving recognition of HLA class I molecules by an extremely diverse set of receptors on the NK cell surface A major group of these receptors are the KIRs Thus a relationship between KIRHLA genotype and psoriasis is biologically plausible and indeed previous data from our laboratory have shown a strong association with the activating genes KIR2DS1 and KIR2DS2 and development of psoriatic arthritis a well-recognized complication of psoriasis

Dr James Elder and colleagues at the University of Michigan have identified a cohort of more than 560 families through the dermatology services of the University of Michigan Medical Center the University of Kiel Henry Ford Hospital and the National Psoriasis Foundation Tissue Bank Individuals have been well characterized clinically and information on race ethnicity age at onset current age and history of inflammatory bowel disease andor other autoimmune disorders has been obtained The large size of the cohort will provide substantial statistical power which is of major importance in any KIRHLA association study

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
04-C-N255 None None None