Pre-analytical Factors Affecting ctDNA Analysis in Early and Locally Advanced Breast Cancer
Study Details
Study Description
Brief Summary
This study evaluates pre-analytical factors affecting circulating tumor deoxyribonucleic acid (ctDNA) analysis in breast cancer that not spread beyond the breast and or lymph nodes (early and locally advanced). ctDNA refers to freely circulating tumor DNA fragments found in the blood plasma. Pre-analytical factors such as blood collection tubes, delays in separation of plasma, centrifugation speeds, storage conditions, shipping and DNA extraction methods can all affect ctDNA measurements. Inappropriate processing can cause breaking down of the membrane (lysis) of peripheral blood cells that release background wild-type DNA and may also cause degradation of circulating tumor-specific DNA fragments. Both mechanisms will dilute levels of ctDNA in plasma and make it more difficult to detect. Evaluating the pre-analytical factors of the collection of blood and left over tissue samples for the research of cancer may help researchers to evaluate the impact of the blood collection/processing and long-term storage from patients with locally advanced breast cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
PRIMARY OBJECTIVES:
- To evaluate the impact of blood collection/processing. II. To evaluate the impact of long-term storage of plasma and extracted DNA.
OUTLINE: This is an observational study.
Patients undergo blood sample collection throughout the study. Patients also undergo collection of leftover tissue samples from standard of care (SOC) procedures and have medical records reviewed.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Observational (Biospecimen collection, medical record) Patients undergo blood sample collection throughout the study. Patients also undergo collection of leftover tissue samples from SOC procedures and have medical records reviewed. |
Procedure: Biospecimen Collection
Undergo blood and leftover tissue sample collection
Other Names:
Other: Electronic Health Record Review
Medical records are reviewed
|
Outcome Measures
Primary Outcome Measures
- Change in tumor specific circulating tumor deoxyribonucleic acid (ctDNA) levels [Baseline to 5 years]
Will be measured as tumor fraction (%), using TARgeted DIgital Sequencing (TARDIS).
Secondary Outcome Measures
- Change in total cell-free DNA concentration [Baseline to 5 years]
Will be measured in genome copies/ml of plasma, using the Quality Assessment (QA) assay.
- Change in total cell-free DNA fragment size profile [Baseline to 5 years]
Will be measured as % fragmented, using the Quality Assessment (QA) assay.
- Change in tumor-specific circulating tumor deoxyribonucleic acid (ctDNA) fragment size profile [Baseline to 5 years]
Will be measured as average fragment size, using TARgeted DIgital Sequencing (TARDIS).
- Background error rate [Baseline to 5 years]
Will be measured as errors per bp sequenced, measured using TARgeted DIgital Sequencing (TARDIS).
Eligibility Criteria
Criteria
Inclusion Criteria:
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All women > 18 years of age
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Stage I-III breast cancer
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Subject has consented to IRB 2130-00 Tissue Registry
Exclusion Criteria:
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Stage IV breast cancer
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Unwilling or unable to give consent
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Unable to participate for 1 year
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No one with a concurrent cancer except those diagnosed with an in situ cancer or non-melanoma skin cancer
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic in Arizona | Scottsdale | Arizona | United States | 85259 |
Sponsors and Collaborators
- Mayo Clinic
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Barbara A Pockaj, M.D., Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 19-012665
- NCI-2022-05844
- 19-012665