Avera Cancer Sequencing and Analytics Protocol (ASAP)

Description

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.

Conditions

Cancer, Cancer Diagnosis, Early Detection of Cancer, Breast Cancer, Lung Cancer, Colon Cancer, GI Cancer, Gynecologic Cancer, Ovarian Cancer, Endometrial Cancer, CNS Cancer, Hematologic Cancer

Study Overview

Study Details

Study overview

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.

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)

Avera Cancer Sequencing and Analytics Protocol (ASAP)

Condition
Cancer
Intervention / Treatment

-

Contacts and Locations

Aberdeen

Avera Cancer Institute - Aberdeen, Aberdeen, South Dakota, United States, 57401

Sioux Falls

Avera Cancer Institute, Sioux Falls, South Dakota, United States, 57105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * Participants incapable of understanding the items listed in the consent form and process
  • * Participants with a history of or known psychiatric illness deemed unable to consent or adhere to study requirements

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Avera McKennan Hospital & University Health Center,

Rachel Elsey, PharmD, PRINCIPAL_INVESTIGATOR, Avera Cancer Institute

Study Record Dates

2026-12-31