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Completed

NCT Number: NCT05945290

Pre-analytical Factors Affecting ctDNA Analysis in Early and Locally Advanced Breast Cancer

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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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All women > 18 years of age
  • Stage I-III breast cancer
  • Subject has consented to IRB 2130-00 Tissue Registry

Exclusion criteria

  • Stage IV breast cancer
  • Unwilling or unable to give consent
  • Unable to participate for 1 year
  • No one with a concurrent cancer except those diagnosed with an in situ cancer or non-melanoma skin cancer

Treatment and study plan

Biospecimen Collection

Procedure

Undergo blood and leftover tissue sample collection

Other names: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Electronic Health Record Review

Other

Medical records are reviewed

Primary outcomes

  1. Change in tumor specific circulating tumor deoxyribonucleic acid (ctDNA) levels

    Time frame: Baseline to 5 years

    Will be measured as tumor fraction (%), using TARgeted DIgital Sequencing (TARDIS).

Secondary outcomes

  1. Change in total cell-free DNA concentration

    Time frame: Baseline to 5 years

    Will be measured in genome copies/ml of plasma, using the Quality Assessment (QA) assay.

  2. Change in total cell-free DNA fragment size profile

    Time frame: Baseline to 5 years

    Will be measured as % fragmented, using the Quality Assessment (QA) assay.

  3. Change in tumor-specific circulating tumor deoxyribonucleic acid (ctDNA) fragment size profile

    Time frame: Baseline to 5 years

    Will be measured as average fragment size, using TARgeted DIgital Sequencing (TARDIS).

  4. Background error rate

    Time frame: Baseline to 5 years

    Will be measured as errors per bp sequenced, measured using TARgeted DIgital Sequencing (TARDIS).

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 14, 2023
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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