Avera Cancer Sequencing and Analytics Protocol (ASAP)

Recruiting

• Conditions: Colon Cancer; GI Cancer; Ovarian Cancer; Cancer Diagnosis; CNS Cancer; Early Detection of Cancer; Hematologic Cancer; Cancer; Breast Cancer; Lung Cancer

• Registration Number: NCT05142033
• Lead Sponsor: Avera McKennan Hospital & University Health Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-01
• Study First Submitted: 2021-11-04
• Study First Submitted QC: 2021-11-18
• Study First Posted: 2021-12-02
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-23
• Last Update Posted: 2024-02-26
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25000

Inclusion 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percent of patients participating in comprehensive molecular profiling	5 years
Percent of patients referred for cascade genetic testing	5 years
Percent of patients referred for molecularly targeted clinical trials	5 years

Secondary Outcome Measures

Name	Time	Method
Percent of patients that had therapy changed due to comprehensive molecular profiling	5 years
Percent of patients that had therapy changed due to pharmacogenomic testing	5 years
Percent of patient participating in microbiome collection and analysis	5 years

Trial Locations

Locations (2)

Avera Cancer Institute - Aberdeen; 🇺🇸 Aberdeen, South Dakota, United States

Avera Cancer Institute; 🇺🇸 Sioux Falls, South Dakota, United States