NCT04306939

Genomic Resources for Enhancing Available Therapies (GREAT1.0) Study

• Status: Suspended
• Phase: —
• Study type: Observational
• Enrollment: 120,000 (estimated)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

The Genomic Resource to Enhance Available Therapies (GREAT1.0) Study is a research program for personalized medicine. It is a highly annotated genetic and biosample resource for multiple nested observational cohort studies. It is designed to begin to understand the mechanisms underlying complex diseases using clinical information from the UPMC electronic health record (EHR), from case-report forms, and from biological samples. Aim 1. To test the hypothesis that point-of-care electronic health record (EHR)-based phenotyping and clinical measures will be useful for classifying patient by disease risk, subtype, activity, complications, quality of life or using statistical or systems approaches. Aim 2. To test the hypothesis that common diseases can be subtyped using genotype data. Aim 3. To test the hypothesis biological samples will provide additional functional and mechanistic information about subject health, disease or state. The study will be conducted using UPMC patients and population controls. Consent will allow EHR and/or case report form data, plus biological samples to be given a unique code number and transferred to researchers for analysis. Consent will also allow for a secure link to be maintained allowing the research data or samples to be updated, and to contact the clinical team and/or subject to provide them with additional information.

Conditions

• Chronic Pancreatitis
• Inflammatory Bowel Diseases
• Hepatitis
• NASH - Nonalcoholic Steatohepatitis
• Acute Pancreatitis
• Rheumatoid Arthritis
• Diabetes Mellitus
• Dyslipidemias
• Multiple Sclerosis
• Irritable Bowel Syndrome
• Chronic Pain
• Chronic Disease
• Chronic Kidney Diseases
• Crohn Disease
• Celiac Disease
• Biliary Cirrhosis
• Bile Acid Synthesis Defect
• Gastritis
• Cholecystitis
• Cholelithiases
• IPMN
• Cyst Pancreas
• Cystic Fibrosis
• Pancreatic Exocrine Insufficiency
• Diarrhea Chronic
• Constipation - Functional
• Constipation Chronic Idiopathic

Interventions

Type	Name	Description
OTHER	venipuncture	Research blood collection is also an option via venipuncture if the subject is not scheduled for clinical testing. This will also be limited to 21cc of blood, up to 4 time a year, and with the approval of the attending physician.
BEHAVIORAL	Questionnaires	PROMIS-43 Profile, PROMIS-29 Profile, Global Health Scale and Hospital Anxiety and Depression Scale (HADS). Additional assessments can be approved and administered per specific disease sub-category.
OTHER	Additional Sample Collections	We may also contact subjects to request additional blood, saliva, cheek swab, hair, urine, or stool with their permission. This will be limited to no more than 4 teaspoons of blood and will happen no more than 4 times per year.

Timeline

• Start date: 2014-11-01
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2020-03-13
• Last updated: 2026-01-07

Locations

1 site across 1 country: United States