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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

114 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-07

Study Completion Date

2025-06-16

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Biospecimen Collection

Intervention Type PROCEDURE

Undergo blood and leftover tissue sample collection

Electronic Health Record Review

Intervention Type OTHER

Medical records are reviewed

Interventions

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Biospecimen Collection

Undergo blood and leftover tissue sample collection

Intervention Type PROCEDURE

Electronic Health Record Review

Medical records are reviewed

Intervention Type OTHER

Other Intervention Names

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Biological Sample Collection Biospecimen Collected Specimen Collection

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No