Rheumatoid Arthritis Clinical Trial
— GREAT1Official title:
Genomic Resources for Enhancing Available Therapies (GREAT1.0) Study
Verified date | July 2023 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This is a prospective, descriptive, observational research study designed to observe and document the clinical practice by domain experts, and how the knowledge of new findings that are published in the medical literature affect clinical decision making. The study will evaluate risk factors and co-variants, including genetic variants that are associated with disease progression such as pain, inflammation, organ dysfunction, disability and quality of life.
Status | Suspended |
Enrollment | 120000 |
Est. completion date | December 1, 2025 |
Est. primary completion date | December 1, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Years and older |
Eligibility | Inclusion Criteria: Case Subjects - Clinical diagnosis of a chronic disease or disorder (ex. pancreatitis, hepatitis or fatty liver, inflammatory bowel disease, irritable bowel syndrome, diarrhea, constipation, chronic pain syndromes, diabetes, hypertension, cardiovascular disease, chronic kidney disease, chronic neurologic disorders, rheumatological disorders, endocrine disorders, chronic pulmonary diseases, sinorespiratory disorders, chronic skin diseases, cancers and related disorders) - Ability to read and write in English; - Ability to provide informed consent Control Subjects • UPMC patients age 12 years without a chronic disorder. Exclusion Criteria: - Chronic infectious disease as the primary medical problem - Less than 12 years of age - Inability of the subject to understand the protocol - Inability to the subject provide informed consent |
Country | Name | City | State |
---|---|---|---|
United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh |
United States,
Whitcomb DC. Primer on Precision Medicine for Complex Chronic Disorders. Clin Transl Gastroenterol. 2019 Jul;10(7):e00067. doi: 10.14309/ctg.0000000000000067. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Define the molecular disorders contributing to clinicopathological disease definitions for common complex disorders | Diseases are defined by symptoms and pathologic features in specific tissues. The study uses genetic variants associated with disease to define the underlying genes associated with disease, and uses cell biology methods to understand which mechanisms within the specialized cells lead to disease under specific conditions. | through study completion, an average of 1 year | |
Primary | Define risk factors for disease progression, severity, complications and poor quality of life. | Life-style (e.g. alcohol, smoking, diet, exercise), medications, metabolic, genetic and epigenetic factors alter the features of disease. Nested studies, subgroup analysis, stepwise regression, statistical and machine learning will be used to develop disease models where early intervention may alter disease progression and severity. | through study completion, an average of 1 year | |
Primary | Common disease mechanisms and repurposing of medications. | Many chronic diseases, including inflammatory and autoimmune diseases, have similar disease features that arise in different organs. Harmonization of similar disease processes in different organs will be used to increase study power, and to determine if there is evidence that therapeutic interventions for one disease may be effective in another disease, providing evidences to consider drug repurposing and new treatment approaches. | through study completion, an average of 1 year | |
Secondary | Pain profile | Pain is measured using visual analogue scales, pain quality, pattern and interference using standardized questionnaires. Patients with similar disease stages and severity often have markedly different levels of pain. Validated tools will be used to observe responses to disease treatments between similar patients, and to observe factors that may be targetable to lessen pain in future intervention studies. | through study completion, an average of 1 year | |
Secondary | Patient Reported Global Health Assessment | PROMIS29 It is a comprehensive measure in that it is assessing multiple aspects of mental, physical, and social health. | through study completion, an average of 1 year |
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