Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-01-03 @ 12:27 AM
Study NCT ID:
NCT05142033
Status:
RECRUITING
Last Update Posted:
2024-02-26
First Post:
2021-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Avera Cancer Sequencing and Analytics Protocol (ASAP)
Sponsor:
Avera McKennan Hospital & University Health Center
Organization:
Study Overview
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)
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ASAP
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: