Clinical trial NCT05945290: Pre-analytical Factors Affecting ctDNA Analysis in Early and Locally Advanced Breast Cancer
Official title: Pre-Analytical Factors Affecting ctDNA Analysis in Early and Locally Advanced Breast Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-07-14
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with stage I-III breast cancer.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in tumor specific circulating tumor deoxyribonucleic acid (ctDNA) levels
timeFrame: Baseline to 5 years
Secondary outcomes:
measure: Change in total cell-free DNA concentration
timeFrame: Baseline to 5 years
measure: Change in total cell-free DNA fragment size profile
timeFrame: Baseline to 5 years
measure: Change in tumor-specific circulating tumor deoxyribonucleic acid (ctDNA) fragment size profile
timeFrame: Baseline to 5 years
measure: Background error rate
timeFrame: Baseline to 5 years
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Barbara A. Pockaj, MD
role: PRINCIPAL_INVESTIGATOR
References: