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NCT05142033Recruiting

Avera Cancer Sequencing and Analytics Protocol (ASAP)

Avera McKennan Hospital & University Health Center

Start Date

11/1/2021

Completion Date

12/31/2026

Summary

The purpose of this study is to characterize the breadth of molecular features present in participants receiving care within a large, integrated, community-based healthcare system. Through comprehensive genomic profiling, investigators aim to identify the underlying genomic drivers of premalignant and malignant conditions across a range of disease stages and cancer types. Comprehensive molecular profiling will include somatic tumor testing (tissue and/or blood) using next-generation sequencing. Selected subsets of samples may undergo whole exome and/or whole transcriptome sequencing for research purposes. Pharmacogenomic testing will also be performed to better understand individual variability in medication response and to identify opportunities for optimizing treatment. In addition, participants may optionally provide microbiome samples. To maximize the value of the genomic data, participants who consent to this protocol will have their electronic health records-both retrospective and prospective-abstracted, curated, annotated, and linked to the genomic data generated through study testing. Given the long-term value of these data, participants may also voluntarily consent to the storage of their biological samples in a biobank and to the use of their de-identified information for future research. Data collected from this participant population will support efforts to advance the understanding of cancer biology, as well as the discovery and validation of biomarkers associated with clinical outcomes. Findings may also be shared through collaborative research initiatives to further promote advancements in cancer research.

Eligibility Criteria

Age Range: 18 years to No maximum

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

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Conditions

CancerCancer DiagnosisEarly Detection of CancerBreast CancerLung CancerColon CancerGI CancerGynecologic CancerOvarian CancerEndometrial CancerCNS CancerHematologic Cancer

Locations

Avera Cancer Institute - Marshall

Marshall, Minnesota 56258

United States

Avera Cancer Institute - Aberdeen

Aberdeen, South Dakota 57401

United States

Avera Cancer Institute - Mitchell

Mitchell, South Dakota 57301

United States

Avera Cancer Institute - Pierre

Pierre, South Dakota 57501

United States

Avera Cancer Institute

Sioux Falls, South Dakota 57105

United States

Avera Cancer Institute - Yankton

Yankton, South Dakota 57078

United States