Implementation of Comprehensive Molecular Profiling and Deep Clinical Annotation of Electronic Health Records in Participants Diagnosed With or at Risk of Developing Cancer (ASAP Study)

What this Trial Is About

Researchers are investigating the wide range of molecular features found in people receiving care within a large community healthcare system who are at risk of or diagnosed with cancer. The study aims to understand the genetic factors behind premalignant and malignant conditions across various cancer types and stages. This research helps advance knowledge of cancer biology and supports the discovery of biomarkers linked to clinical outcomes. Participants will undergo comprehensive molecular profiling, including somatic tumor testing from tissue and/or blood samples using next-generation sequencing. Some samples may also receive whole exome or transcriptome sequencing for research purposes. Pharmacogenomic testing will help explore how individuals respond differently to medications, and participants may optionally provide microbiome samples. Participants may also consent to store biological samples in a biobank and allow their de-identified data to be used for future research. During the study, electronic health records will be reviewed both retrospectively and prospectively to connect clinical data with genomic findings. Researchers will measure how many patients undergo molecular profiling, are referred for genetic testing or targeted clinical trials, and have therapy changes based on molecular or pharmacogenomic results. The study spans five years, with long-term follow-up and data collection to support ongoing research and collaboration in cancer studies.

Avera Cancer Sequencing and Analytics Protocol (ASAP)