Avera Cancer Sequencing and Analytics Protocol (ASAP)

Last updated: February 23, 2024
Sponsor: Avera McKennan Hospital & University Health Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Ovarian Cancer

Lung Cancer

Hematologic Cancer

Treatment

N/A

Clinical Study ID

NCT05142033
ASAP Protocol
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to understand the breadth of molecular characteristics present in participants cared for in a large integrated, community-based health care system. Using comprehensive genomic profiling and proteomics, the investigators seek to identify the underlying genomic drivers of premalignant or malignant conditions in participants across different stages of disease development and cancer types.

Comprehensive molecular profiling will consist of somatic tumor testing (tissue and/or blood) using whole exome sequencing, whole transcriptome sequencing, proteomics, and selected instances of whole genome sequencing. In addition, the investigators seek to perform broad hereditary cancer testing in affected participant populations. Hereditary testing has implications in screening, prognosis, and therapeutics for affected participants, as well as broad implications for genetic counseling and cascade testing.

In order to maximize the value of genomic information, participants consented to this protocol will have their electronic health records (both retrospectively and prospectively) abstracted, curated, annotated and linked to genomic information obtained though the testing performed. Given the long-term value of this data, participants will also be asked to voluntarily consent to have their samples stored in a biobank and have their de-identified information used for future research.

Information collected across this participant population will aid in advancing the investigators' knowledge of cancer biology, to discover and validate biomarkers associated with clinical outcomes, and shared in collaborative projects in order to promote the study of cancer.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Must be at least 18 years of age
  • Must be undergoing a workup or being followed for a premalignant condition or have adiagnosis of cancer
  • Must voluntarily sign and understand the most current IRB-approved consent form priorto study participation

Exclusion

Exclusion Criteria:

  • Participants incapable of understanding the items listed in the consent form andprocess
  • Participants with a history of or known psychiatric illness deemed unable to consentor adhere to study requirements

Study Design

Total Participants: 25000
Study Start date:
November 01, 2021
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Avera Cancer Institute - Aberdeen

    Aberdeen, South Dakota 57401
    United States

    Active - Recruiting

  • Avera Cancer Institute

    Sioux Falls, South Dakota 57105
    United States

    Active - Recruiting

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