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

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.

Study Overview

• Status: Recruiting
• Conditions: Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Locally Advanced Breast Carcinoma; Early Stage Breast Carcinoma
• Intervention / Treatment: Other: Electronic Health Record Review; Procedure: Biospecimen Collection

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Clinical Trials Referral Office; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Recruiting
      • Mayo Clinic in Arizona
      • Principal Investigator: Barbara A. Pockaj, M.D.
      • Contact: Clinical Trials Marenco Hillembrand; Phone Number: 855-776-0015; Email: mayocliniccancerstudies@mayo.edu
      • Contact: Barbara A. Pockaj; Phone Number: 480-301-8000; Email: pockaj.barbara@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with stage I-III breast cancer.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.	Other: Electronic Health Record Review; Medical records are reviewed; Procedure: Biospecimen Collection; Undergo blood and leftover tissue sample collection; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in tumor specific circulating tumor deoxyribonucleic acid (ctDNA) levels	Will be measured as tumor fraction (%), using TARgeted DIgital Sequencing (TARDIS).	Baseline to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in total cell-free DNA concentration	Will be measured in genome copies/ml of plasma, using the Quality Assessment (QA) assay.	Baseline to 5 years
Change in total cell-free DNA fragment size profile	Will be measured as % fragmented, using the Quality Assessment (QA) assay.	Baseline to 5 years
Change in tumor-specific circulating tumor deoxyribonucleic acid (ctDNA) fragment size profile	Will be measured as average fragment size, using TARgeted DIgital Sequencing (TARDIS).	Baseline to 5 years
Background error rate	Will be measured as errors per bp sequenced, measured using TARgeted DIgital Sequencing (TARDIS).	Baseline to 5 years

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Barbara A. Pockaj, M.D., Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2022
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: July 6, 2023
• First Submitted That Met QC Criteria: July 6, 2023
• First Posted (Actual): July 14, 2023

Study Record Updates

• Last Update Posted (Estimated): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Breast Diseases; Breast Neoplasms; Carcinoma
• Other Study ID Numbers: 19-012665 (Other Identifier: Mayo Clinic in Arizona); NCI-2022-05844 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); UH2CA234306 (U.S. NIH Grant/Contract); U01CA243078 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No