NCT05142033

Avera Cancer Sequencing and Analytics Protocol (ASAP)

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
• Phase: —
• Study type: Observational
• Enrollment: 25,000 (estimated)
• Sponsor: Avera McKennan Hospital & University Health Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

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

Timeline

• Start date: 2021-11-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2021-12-02
• Last updated: 2026-03-27

Locations

6 sites across 1 country: United States