Tab Title Description
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
- Rochester, Minnesota: 19-012484
About this study
Aim 1 (Epidemiology). To describe the disease trajectory under current clinical care; to estimate event rates for clinically meaningful outcomes; to identify patient characteristics (demographic, clinical, laboratory, environmental) associated with glomerular disease and non-renal complications of disease; to identify clinical predictors of short- and long-term outcomes, including therapeutic response; and to evaluate intermediate outcomes, such as proteinuria, as potential surrogates for longer-term outcomes.
Aim 2 (Biomarkers). To identify and characterize clinical, histological, molecular, and genetic biomarkers that are linked to glomerular disease, disease outcomes, or that might be used to improve disease classification; to identify and characterize biomarkers that may be employed in clinical practice or clinical trials to predict disease trajectory, disease activity, or response to therapy.
Aim 3 (Genetics). To understand the genetic architecture of the four glomerulopathies, including studies of germline sequence variation, somatic mutations, epigenetic changes, and transcriptomic profile, and their impact on disease presentation and clinical outcome; study gene-gene and gene-environment interactions that contribute to the development of the four glomerulopathies; and devise systems genetics approach to clarify pathogenesis.
Aim 4 (PROs). To identify Patient Reported Outcomes (PROs, e.g., symptom burden, physical function, quality of life) associated with primary glomerular diseases; to validate disease-specific instrument(s) to assess the impact of disease and its therapy on patients; and to test the associations of PROs with disease progression.