Understanding cancer through genomic profiling and analytics
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)
This study is trying to understand the genetic features of different types of cancer in people from a community healthcare system to improve screening and treatment options.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Avera McKennan Hospital & University Health Center Academic / other |
| Locations | 6 sites (Marshall, Minnesota and 5 other locations) |
| Trial ID | NCT05142033 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the molecular characteristics of cancer in participants from a large community-based healthcare system. By utilizing comprehensive genomic profiling and proteomics, the study seeks to identify genomic drivers of both premalignant and malignant conditions across various cancer types. Participants will undergo somatic tumor testing and hereditary cancer testing to enhance screening, prognosis, and therapeutic strategies. The findings may also have implications for genetic counseling and cascade testing for families.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are undergoing evaluation for a premalignant condition or have a cancer diagnosis.
Not a fit: Patients who are unable to understand the consent process or have psychiatric conditions that prevent them from participating may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection and personalized treatment strategies for cancer patients.
How similar studies have performed: Other studies utilizing genomic profiling in cancer diagnosis have shown promising results, indicating that this approach is supported by prior successes.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Marshall, Minnesota and 5 other locations
- Avera Cancer Institute - Marshall — Marshall, Minnesota, United States (Recruiting)
- Avera Cancer Institute - Aberdeen — Aberdeen, South Dakota, United States (Recruiting)
- Avera Cancer Institute - Mitchell — Mitchell, South Dakota, United States (Recruiting)
- Avera Cancer Institute - Pierre — Pierre, South Dakota, United States (Recruiting)
- Avera Cancer Institute — Sioux Falls, South Dakota, United States (Recruiting)
- Avera Cancer Institute - Yankton — Yankton, South Dakota, United States (Recruiting)
Study contacts
- Principal investigator: Rachel Elsey, PharmD — Avera Cancer Institute
- Study coordinator: Rachel Elsey, PharmD
- Email: Rachel.Elsey@avera.org
- Phone: 605-322-3225
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.