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Trial Title:
Pre-analytical Factors Affecting ctDNA Analysis in Early and Locally Advanced Breast Cancer
NCT ID:
NCT05945290
Condition:
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
Conditions: Official terms:
Carcinoma
Breast Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood and leftover tissue sample collection
Arm group label:
Observational (Biospecimen collection, medical record)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Other
Intervention name:
Electronic Health Record Review
Description:
Medical records are reviewed
Arm group label:
Observational (Biospecimen collection, medical record)
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.
Criteria for eligibility:
Study pop:
Patients with stage I-III breast cancer.
Sampling method:
Non-Probability Sample
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic in Arizona
Address:
City:
Scottsdale
Zip:
85259
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Marenco Hillembrand
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Contact backup:
Last name:
Barbara A. Pockaj
Phone:
480-301-8000
Email:
pockaj.barbara@mayo.edu
Investigator:
Last name:
Barbara A. Pockaj, M.D.
Email:
Principal Investigator
Start date:
July 7, 2022
Completion date:
December 2025
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05945290
https://www.mayo.edu/research/clinical-trials
