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Avera Cancer Sequencing and Analytics Protocol (ASAP)

RECRUITINGSponsored by Avera McKennan Hospital & University Health Center
Actively Recruiting
SponsorAvera McKennan Hospital & University Health Center
Started2021-11-01
Est. completion2026-12-31
Eligibility
Age18 Years+
Locations6 sites

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

Age: 18 Years+
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

Conditions12

Breast CancerCNS CancerCancerCancer DiagnosisColon CancerEarly Detection of CancerEndometrial CancerGI CancerGynecologic CancerHematologic Cancer

Locations6 sites

Avera Cancer Institute - Marshall
Marshall, Minnesota, 56258
Rachel Elsey, PharmD605-322-3225rachel.elsey@avera.org
Avera Cancer Institute - Aberdeen
Aberdeen, South Dakota, 57401
Rachel Elsey, PharmD605-322-3225Rachel.Elsey@avera.org
Avera Cancer Institute - Mitchell
Mitchell, South Dakota, 57301
Rachel Elsey, PharmD605-322-3225rachel.elsey@avera.org
Avera Cancer Institute - Pierre
Pierre, South Dakota, 57501
Rachel Elsey, PharmD605-322-3225rachel.elsey@avera.org
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
Rachel Elsey, PharmD605-322-3225Rachel.Elsey@avera.org

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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