RecruitingNCT05142033

Avera Cancer Sequencing and Analytics Protocol (ASAP)

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)


Sponsor

Avera McKennan Hospital & University Health Center

Enrollment

25,000 participants

Start Date

Nov 1, 2021

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study, called ASAP (Avera Cancer Sequencing and Analytics Protocol), collects genetic information from patients with cancer or pre-cancerous conditions. The goal is to analyze this data to better understand cancer and improve future treatments and prevention strategies. **You may be eligible if...** - You are at least 18 years old - You have been diagnosed with cancer, or you are being monitored for a pre-cancerous condition - You are willing and able to sign the consent form **You may NOT be eligible if...** - You are not able to understand the consent process - You have a psychiatric condition that would prevent you from participating or following the study requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(6)

Avera Cancer Institute - Marshall

Marshall, Minnesota, United States

Avera Cancer Institute - Aberdeen

Aberdeen, South Dakota, United States

Avera Cancer Institute - Mitchell

Mitchell, South Dakota, United States

Avera Cancer Institute - Pierre

Pierre, South Dakota, United States

Avera Cancer Institute

Sioux Falls, South Dakota, United States

Avera Cancer Institute - Yankton

Yankton, South Dakota, United States

View Full Details on ClinicalTrials.gov

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NCT05142033


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