Recruiting

Observational Study

Sponsor:

Avera McKennan Hospital & University Health Center

Code:

NCT05142033

Conditions

Cancer

Cancer Diagnosis

Early Detection of Cancer

Breast Cancer

Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Cancer

Cancer Diagnosis

Early Detection of Cancer

Breast Cancer

Lung Cancer

Study ID

NCT05142033

Start date

Nov 1, 2021

Status verified date

Mar, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

25000 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

Avera Cancer Institute - Marshall

Recruiting

Marshall, Minnesota, United States, 56258

Contacts

Avera Cancer Institute - Aberdeen

Recruiting

Aberdeen, South Dakota, United States, 57401

Contacts

Avera Cancer Institute - Mitchell

Recruiting

Mitchell, South Dakota, United States, 57301

Contacts

Avera Cancer Institute - Pierre

Recruiting

Pierre, South Dakota, United States, 57501

Contacts

Avera Cancer Institute

Recruiting

Sioux Falls, South Dakota, United States, 57105

Contacts

Avera Cancer Institute - Yankton

Recruiting

Yankton, South Dakota, United States, 57078

Contacts

More Information

Sponsor

Avera McKennan Hospital & University Health Center

Last update posted

Mar 27, 2026

Last verified

Mar, 2025

Keywords

  • Cancer
  • Genomics
  • Genetics
  • Microbiome
  • Pharmacogenomics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Avera McKennan Hospital & University Health Center on 2026-03-27.