- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00341809
Genetic Analysis of Psoriasis and Psoriatic Arthritis
Role of HLA and KIR in the Natural History of Psoriasis
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
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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-Cw*0602. 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 KIR/HLA 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 and/or other autoimmune disorders has been obtained. The large size of the cohort will provide substantial statistical power, which is of major importance in any KIR/HLA association study.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
Michigan
-
Ann Arbor, Michigan, États-Unis, 48109-0624
- University of Michigan
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
- INCLUSION CRITERIA:
DNA and relevant clinical data from properly consented subjects will be provided to the LGD for genotyping and analysis. No available subjects will be excluded.
Plan d'étude
Comment l'étude est-elle conçue ?
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- Elder JT, Nair RP, Guo SW, Henseler T, Christophers E, Voorhees JJ. The genetics of psoriasis. Arch Dermatol. 1994 Feb;130(2):216-24.
- Bhalerao J, Bowcock AM. The genetics of psoriasis: a complex disorder of the skin and immune system. Hum Mol Genet. 1998;7(10):1537-45. doi: 10.1093/hmg/7.10.1537.
- Nair RP, Henseler T, Jenisch S, Stuart P, Bichakjian CK, Lenk W, Westphal E, Guo SW, Christophers E, Voorhees JJ, Elder JT. Evidence for two psoriasis susceptibility loci (HLA and 17q) and two novel candidate regions (16q and 20p) by genome-wide scan. Hum Mol Genet. 1997 Aug;6(8):1349-56. doi: 10.1093/hmg/6.8.1349.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement de l'étude
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 999904255
- 04-C-N255
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .