Avera Cancer Sequencing and Analytics Protocol (ASAP) (ASAP)
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| ClinicalTrials.gov Identifier: NCT05142033 |
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Recruitment Status :
Recruiting
First Posted : December 2, 2021
Last Update Posted : February 26, 2024
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Sponsor:
Avera McKennan Hospital & University Health Center
Information provided by (Responsible Party):
Avera McKennan Hospital & University Health Center
| Tracking Information | |||||||||
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| First Submitted Date | November 4, 2021 | ||||||||
| First Posted Date | December 2, 2021 | ||||||||
| Last Update Posted Date | February 26, 2024 | ||||||||
| Actual Study Start Date | November 1, 2021 | ||||||||
| Estimated Primary Completion Date | December 31, 2026 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | 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) | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Other Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: Retention: Samples with DNA/RNA, and protein Description: Tissue, blood, stool, saliva, skin
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| Sampling Method | Probability Sample | ||||||||
| Study Population | Participants with a premalignant or malignant condition and able/willing to consent/participate in the study. | ||||||||
| Condition |
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| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts | Not Provided | ||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
25000 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | December 31, 2026 | ||||||||
| Estimated Primary Completion Date | December 31, 2026 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | Not Provided | ||||||||
| Contacts |
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| Listed Location Countries | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT05142033 | ||||||||
| Other Study ID Numbers | ASAP Protocol | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||||||
| Current Responsible Party | Avera McKennan Hospital & University Health Center | ||||||||
| Original Responsible Party | Same as current | ||||||||
| Current Study Sponsor | Avera McKennan Hospital & University Health Center | ||||||||
| Original Study Sponsor | Same as current | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | Avera McKennan Hospital & University Health Center | ||||||||
| Verification Date | February 2024 | ||||||||