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)

Status: Recruiting
Location: See all (2) locations...
Study Type: Observational
SUMMARY

The purpose of this study is to understand the breadth of molecular characteristics present in participants cared for in a large integrated, community-based health care system. Using comprehensive genomic profiling and proteomics, the investigators seek to identify the underlying genomic drivers of premalignant or malignant conditions in participants across different stages of disease development and cancer types. Comprehensive molecular profiling will consist of somatic tumor testing (tissue and/or blood) using whole exome sequencing, whole transcriptome sequencing, proteomics, and selected instances of whole genome sequencing. In addition, the investigators seek to perform broad hereditary cancer testing in affected participant populations. Hereditary testing has implications in screening, prognosis, and therapeutics for affected participants, as well as broad implications for genetic counseling and cascade testing. In order to maximize the value of genomic information, participants consented to this protocol will have their electronic health records (both retrospectively and prospectively) abstracted, curated, annotated and linked to genomic information obtained though the testing performed. Given the long-term value of this data, participants will also be asked to voluntarily consent to have their samples stored in a biobank and have their de-identified information used for future research. Information collected across this participant population will aid in advancing the investigators' knowledge of cancer biology, to discover and validate biomarkers associated with clinical outcomes, and shared in collaborative projects in order to promote the study of cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
View:

• Must be at least 18 years of age

• Must be undergoing a workup or being followed for a premalignant condition or have a diagnosis of cancer

• Must voluntarily sign and understand the most current IRB-approved consent form prior to study participation

Locations
United States
South Dakota
Avera Cancer Institute - Aberdeen
RECRUITING
Aberdeen
Avera Cancer Institute
RECRUITING
Sioux Falls
Contact Information
Primary
Rachel Elsey, PharmD
Rachel.Elsey@avera.org
605-322-3225
Backup
Martha Lang, RN
precisionresearch@avera.org
605-322-3228
Time Frame
Start Date: 2021-11-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 25000
Authors
Casey Williams
Sponsors
Leads: Avera McKennan Hospital & University Health Center

This content was sourced from clinicaltrials.gov