Clinical trial · Observational
Genomic Resources for Enhancing Available Therapies (GREAT1.0) Study
NCT04306939CI-TRIAL-00100275GREAT1suspendedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Suspended for analysis and to consider further enrollment.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (27)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Pancreatitis | — | UNRESOLVED | — |
| Bile Acid Synthesis Defect | — | UNRESOLVED | — |
| Biliary Cirrhosis | — | UNRESOLVED | — |
| Celiac Disease | — | UNRESOLVED | — |
| Cholecystitis | — | UNRESOLVED | — |
| Cholelithiases | — | UNRESOLVED | — |
| Chronic Disease | — | UNRESOLVED | — |
| Chronic Kidney Diseases | — | UNRESOLVED | — |
| Chronic Pain | — | UNRESOLVED | — |
| Chronic Pancreatitis | — | UNRESOLVED | — |
| Constipation Chronic Idiopathic | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Additional Sample Collections | Other | — | UNRESOLVED |
| Questionnaires | Behavioral | — | UNRESOLVED |
| venipuncture | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Case/Chronic complex disorders
- description
- Chronic complex disorders are composed of multiple population sub classifications - many of which have not been fully defined. Thus, all eligible patients should be included to maximize study power. Sufficient numbers of controls, those individuals in the general population, who may or may not have complex disorders are needed to match future comparison studies for a subset of questions, and so should also be included.
- interventionNames
- Other: venipuncture
- Behavioral: Questionnaires
- Other: Additional Sample Collections
- label
- Control
- description
- The number of controls that are anticipated for this study is less than patient numbers since they will not be needed for calculating the minor allele frequency of the majority of genetic polymorphism of interest in genetic association studies. This data is already available in public and research databases. Controls will be useful for evaluating case report form questions, providing assessment of the local genetic pool, and for possibly participating in future studies as provided by the consent.
- interventionNames
- Other: venipuncture
- Behavioral: Questionnaires
- Other: Additional Sample Collections
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDWhitcomb DC. Primer on Precision Medicine for Complex Chronic Disorders. Clin Transl Gastroenterol. 2019 Jul;10(7):e00067. doi: 10.14309/ctg.0000000000000067. PMID 31335357