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NCT05142033Recruiting

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)

Source: ClinicalTrials.gov · Last updated 28 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
25000 (estimated)
First submitted
4 Nov 2021
Start date
1 Nov 2021
Primary completion date
31 Dec 2026
Lead sponsor
Avera McKennan Hospital & University Health Center
NCT number
NCT05142033

What you commit to

  • Study type: Observational
  • Planned participants: 25000
  • From 1 Nov 2021 to the primary completion date, 31 Dec 2026
  • 6 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Participants with a history of or known psychiatric illness deemed unable to consent or adhere to study requirements

Other

  • Participants incapable of understanding the items listed in the consent form and process

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Avera Cancer Institute-Aberdeen
Coordinator of this site? Confirm its status
AberdeenUnited StatesRecruiting
Avera Cancer Institute - Marshall
Coordinator of this site? Confirm its status
MarshallUnited StatesRecruiting
Avera Cancer Institute - Mitchell
Coordinator of this site? Confirm its status
MitchellUnited StatesRecruiting
Avera Cancer Institute - Pierre
Coordinator of this site? Confirm its status
PierreUnited StatesRecruiting
Avera Cancer Institute
Coordinator of this site? Confirm its status
Sioux FallsUnited StatesRecruiting
Avera Cancer Institute - Yankton
Coordinator of this site? Confirm its status
YanktonUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.