Breast Cancer Clinical Trial

Avera Cancer Sequencing and Analytics Protocol (ASAP)

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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Breast Cancer

Estimated Enrollment:

25000

Study ID:

NCT05142033

Recruitment Status:

Recruiting

Sponsor:

Avera McKennan Hospital & University Health Center

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There are 2 Locations for this study

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Avera Cancer Institute - Aberdeen
Aberdeen South Dakota, 57401, United States More Info
Rachel Elsey, PharmD
Contact
605-322-3225
[email protected]
Avera Cancer Institute
Sioux Falls South Dakota, 57105, United States More Info
Rachel Elsey, PharmD
Contact
605-322-3225
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

25000

Study ID:

NCT05142033

Recruitment Status:

Recruiting

Sponsor:


Avera McKennan Hospital & University Health Center

How clear is this clinincal trial information?

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