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

Mayo Clinic

Status: Enrolling

Conditions: Anatomic Stage III Breast Cancer AJCC V8; Anatomic Stage II Breast Cancer AJCC V8; Locally Advanced Breast Carcinoma; Anatomic Stage I Breast Cancer AJCC V8; Early Stage Breast Carcinoma

Treatments: Procedure: Biospecimen Collection; Other: Electronic Health Record Review

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT05945290

19-012665 (Other Identifier)

U01CA243078 (U.S. NIH Grant/Contract)

NCI-2022-05844 (Registry Identifier)

UH2CA234306 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

120 participants in 1 patient group

Observational (Biospecimen collection, medical record)

Description:

Patients undergo blood sample collection throughout the study. Patients also undergo collection of leftover tissue samples from SOC procedures and have medical records reviewed.

Treatment:

Other: Electronic Health Record Review

Procedure: Biospecimen Collection