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

NCT05945290 | Completed

• 4 other identifiers: 19-012665UH2CA234306U01CA243078NCI-2022-05844
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Early Stage Breast Carcinoma; Locally Advanced Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in total cell-free DNA concentration

  Baseline to 5 years

• Change in total cell-free DNA fragment size profile

  Baseline to 5 years

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

  Baseline to 5 years

• Background error rate

  Baseline to 5 years

Study Arms (1)

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; Other: Electronic Health Record Review

Interventions

Biospecimen Collection PROCEDURE

Undergo blood and leftover tissue sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Observational (Biospecimen collection, medical record)

Electronic Health Record Review OTHER

Medical records are reviewed

Observational (Biospecimen collection, medical record)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with stage I-III breast cancer.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

Blood, tissue

MeSH Terms

Interventions

Specimen Handling

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Barbara A. Pockaj, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 14, 2023
• Study Start: July 7, 2022
• Primary Completion: June 16, 2025
• Study Completion: June 16, 2025
• Last Updated: September 9, 2025

Record last verified: 2025-09

Locations

US (1)