CPMC Early Undifferentiated Arthritis Registry (CEUAR)
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|ClinicalTrials.gov Identifier: NCT02353221|
Recruitment Status : Recruiting
First Posted : February 2, 2015
Last Update Posted : January 23, 2020
The CPMC early arthritis registry will recruit participants from a population of new patients undergoing evaluation at the office of participating physicians. Patients enrolled in the registry will undergo longitudinal observation and sampling. The investigators will collect questionnaire data and create a biological sample repository. The information obtained will be use to generate hypotheses aimed at explaining how environmental and genetic factors are interrelated to influence UA disease outcomes. Analysis will be performed on the patient's data and biological samples in order to; A. Assess the epidemiological and clinical characteristics of patients with early arthritis in the referral pool at CPMC.
B. Analyze the phenotype and genotype of peripheral blood mononuclear cells (PBMC) from individual patients based on their chemokine/cytokine secretion, cell adhesion molecule expression, gene expression, DNA methylation and non coding RNA profiles.
C. Generate hypothesis aimed to identify clinical criteria and novel biomarkers to be used in the diagnosis, prognosis, and therapeutic decisions for patients with early UA
|Condition or disease|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||500 participants|
|Target Follow-Up Duration:||12 Months|
|Official Title:||California Pacific Medical Center Early Undifferentiated Arthritis Registry|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Entry criteria include being at least 18 years old at screening visit, being able to understand the information given to them and to give written informed consent, willingness to comply with the requirements of the data collection, absence of a diagnose of autoimmune disease or inflammatory arthritis, and absence of a previous treatment with any disease modifying anti-rheumatic drug (DMARD). We will exclude patients that are pregnant or intend to become pregnant during the time of follow up.
Healthy control subjects will be recruited based on similar criteria as study subjects. Our effort will be to include age and gender matched control subjects in the registry. We will be also aiming to match environmental characteristics (i.e. partners living in same location as registry subject or in a radius of 10 miles for at least one year previous to the date of evaluation) or genetic background (i.e. by asking the participation of first-degree relatives)
- Diagnosis of inflammatory arthritis [ Time Frame: one year ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02353221
|Contact: Pedro J Ruiz, MD PhD||(415) firstname.lastname@example.org|
|Contact: Carla Bello||(415) 600 email@example.com|
|United States, California|
|California Pacific Medical Center||Recruiting|
|San Francisco, California, United States, 94115|
|Principal Investigator:||Pedro J. Ruiz, MD PhD||CPMCRI|