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

Anatomic Stage III Breast Cancer AJCC v8 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05945290
• Other study ID #: 19-012665
• Secondary ID: NCI-2022-0584419
• Status: Recruiting
• Start date: July 7, 2022
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Biospecimen Collection
Undergo blood and leftover tissue sample collection

Other:
• Electronic Health Record Review
Medical records are reviewed

Locations

Country	Name	City	State
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Change in total cell-free DNA fragment size profile	Will be measured as % fragmented, using the Quality Assessment (QA) assay.	Baseline to 5 years
Secondary	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
Secondary	Background error rate	Will be measured as errors per bp sequenced, measured using TARgeted DIgital Sequencing (TARDIS).	Baseline to 5 years

External Links

•   Mayo Clinic Clinical Trials