Evaluating factors affecting blood tests for early breast cancer
Pre-Analytical Factors Affecting ctDNA Analysis in Early and Locally Advanced Breast Cancer
Mayo Clinic · NCT05945290
This study is testing how different ways of collecting and handling blood samples can affect the accuracy of blood tests that look for early signs of breast cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Mayo Clinic (other) |
| Locations | 1 site (Scottsdale, Arizona) |
| Trial ID | NCT05945290 on ClinicalTrials.gov |
What this trial studies
This observational study investigates how various pre-analytical factors influence the analysis of circulating tumor DNA (ctDNA) in patients with early and locally advanced breast cancer. It focuses on aspects such as blood collection methods, delays in plasma separation, centrifugation speeds, and storage conditions that may affect ctDNA measurements. By collecting blood samples and leftover tissue from standard care procedures, the study aims to identify optimal practices for processing these samples to improve ctDNA detection. The findings could enhance the accuracy of ctDNA analysis in clinical settings.
Who should consider this trial
Good fit: Ideal candidates for this study are women over 18 years of age diagnosed with Stage I-III breast cancer.
Not a fit: Patients with Stage IV breast cancer or those unwilling to provide consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved detection and monitoring of breast cancer through more reliable ctDNA analysis.
How similar studies have performed: Other studies have shown that optimizing pre-analytical factors can significantly improve the reliability of ctDNA analysis, indicating that this approach is promising.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Scottsdale, Arizona
- Mayo Clinic in Arizona — Scottsdale, Arizona, United States (RECRUITING)
Study contacts
- Principal investigator: Barbara A. Pockaj, MD — Mayo Clinic
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
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