Breast Cancer, Cancer, Cancer Diagnosis, CNS Cancer, Colon Cancer, Early Detection of Cancer, Endometrial Cancer, GI Cancer, Gynecologic Cancer, Hematologic Cancer, Lung Cancer, Ovarian Cancer
Conditions
Keywords
Cancer, Genomics, Genetics, Microbiome, Pharmacogenomics
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.
Interventions
None listed
Sponsors
Avera McKennan Hospital & University Health Center
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent of patients participating in comprehensive molecular profiling | 5 years |
| Percent of patients referred for cascade genetic testing | 5 years |
| Percent of patients referred for molecularly targeted clinical trials | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Percent of patients that had therapy changed due to comprehensive molecular profiling | 5 years |
| Percent of patients that had therapy changed due to pharmacogenomic testing | 5 years |
| Percent of patient participating in microbiome collection and analysis | 5 years |
Countries
United States
Contacts
CONTACTRachel Elsey, PharmD
CONTACTAvera Precision Research Team
PRINCIPAL_INVESTIGATORRachel Elsey, PharmD
Avera Cancer Institute
Outcome results
None listed