Description

This is a master protocol that enables investigators to conduct observational research and correlative biospecimen studies. This study is non-therapeutic, with retrospective and prospective components. This will be a single-site study at MCW/FH. Retrospective data and, with consent, prospective observational data will be collected. The study will also include an opportunity for patients to consent to the analysis of specimens collected prospectively during care and for the collection of research-related testing of blood, stool, and/or urine. It is designed to decrease the burden on both patients and investigators by allowing consent to a protocol that will enable multiple minimal-risk studies.

Studies under this master protocol may perform data analysis using standard statistical techniques, as well as with advanced bioinformatics, machine learning, artificial intelligence, and other related technologies.

Collection and testing of biospecimens will only be performed if a proposed study that falls under this master protocol requires it. Studies may include a variety of simple or advanced techniques related to chemical, hematologic, molecular, proteomic, transcriptomic, immunomic, and metabolic analyses, as well as related multi-omic analysis for biomarker discovery, understanding correlations between treatment and molecular features, and/or for pharmacokinetic (PK) and pharmacodynamic (PD) parameters.