Avera Cancer Sequencing and Analytics Protocol (ASAP) (ASAP)

March 23, 2026 updated by: Avera McKennan Hospital & University Health Center

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)

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

25000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Minnesota
      • Marshall, Minnesota, United States, 56258
        • Recruiting
        • Avera Cancer Institute - Marshall
        • Contact:
    • South Dakota
      • Aberdeen, South Dakota, United States, 57401
        • Recruiting
        • Avera Cancer Institute - Aberdeen
        • Contact:
      • Mitchell, South Dakota, United States, 57301
        • Recruiting
        • Avera Cancer Institute - Mitchell
        • Contact:
      • Pierre, South Dakota, United States, 57501
        • Recruiting
        • Avera Cancer Institute - Pierre
        • Contact:
      • Sioux Falls, South Dakota, United States, 57105
        • Recruiting
        • Avera Cancer Institute
        • Contact:
      • Yankton, South Dakota, United States, 57078
        • Recruiting
        • Avera Cancer Institute - Yankton
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Participants with a premalignant or malignant condition and able/willing to consent/participate in the study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent of patients participating in comprehensive molecular profiling
Time Frame: 5 years
5 years
Percent of patients referred for cascade genetic testing
Time Frame: 5 years
5 years
Percent of patients referred for molecularly targeted clinical trials
Time Frame: 5 years
5 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Avera McKennan Hospital & University Health Center

Collaborators

Sema4

Investigators

  • Principal Investigator: Rachel Elsey, PharmD, Avera Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

November 4, 2021

First Submitted That Met QC Criteria

November 18, 2021

First Posted (Actual)

December 2, 2021

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASAP Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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