Clinical trial NCT05142033: Avera Cancer Sequencing and Analytics Protocol (ASAP)
Official title: 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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Cancer Diagnosis
Early Detection of Cancer
Breast Cancer
Lung Cancer
Colon Cancer
GI Cancer
Gynecologic Cancer
Ovarian Cancer
Endometrial Cancer
CNS Cancer
Hematologic Cancer
Keywords: Cancer
Genomics
Genetics
Microbiome
Pharmacogenomics
Lead sponsor: Avera McKennan Hospital & University Health Center
Sponsor class: OTHER
First posted: 2021-12-02
Enrollment: 25000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with a premalignant or malignant condition and able/willing to consent/participate in the study.

Brief 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 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

Primary outcomes:
measure: Percent of patients participating in comprehensive molecular profiling
timeFrame: 5 years
measure: Percent of patients referred for cascade genetic testing
timeFrame: 5 years
measure: Percent of patients referred for molecularly targeted clinical trials
timeFrame: 5 years
Secondary outcomes:
measure: Percent of patients that had therapy changed due to comprehensive molecular profiling
timeFrame: 5 years
measure: Percent of patients that had therapy changed due to pharmacogenomic testing
timeFrame: 5 years
measure: Percent of patient participating in microbiome collection and analysis
timeFrame: 5 years
Other outcomes:
Locations:
city: Aberdeen
country: United States
facility: Avera Cancer Institute - Aberdeen
state: South Dakota
city: Sioux Falls
country: United States
facility: Avera Cancer Institute
state: South Dakota
Study officials:
affiliation: Avera Cancer Institute
name: Rachel Elsey, PharmD
role: PRINCIPAL_INVESTIGATOR
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