Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
NCT Number: NCT05945290
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.
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Notify Me18 year and older
Female
Observational
Scottsdale, Arizona, 85259, United States
PRIMARY OBJECTIVES:
I. 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Undergo blood and leftover tissue sample collection
Other names: Biological Sample Collection, Biospecimen Collected, Specimen Collection
Medical records are reviewed
Time frame: Baseline to 5 years
Will be measured as tumor fraction (%), using TARgeted DIgital Sequencing (TARDIS).
Time frame: Baseline to 5 years
Will be measured in genome copies/ml of plasma, using the Quality Assessment (QA) assay.
Time frame: Baseline to 5 years
Will be measured as % fragmented, using the Quality Assessment (QA) assay.
Time frame: Baseline to 5 years
Will be measured as average fragment size, using TARgeted DIgital Sequencing (TARDIS).
Time frame: Baseline to 5 years
Will be measured as errors per bp sequenced, measured using TARgeted DIgital Sequencing (TARDIS).
Mayo Clinic
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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