NCT05945290Completed
Pre-analytical Factors Affecting ctDNA Analysis in Early and Locally Advanced Breast Cancer
Source: ClinicalTrials.gov · Last updated 9 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 114 (actual)
- First submitted
- 6 Jul 2023
- Start date
- 7 Jul 2022
- Primary completion date
- 16 Jun 2025
- Lead sponsor
- Mayo Clinic
- Diseases
- Metastatic breast cancer
- NCT number
- NCT05945290
What you commit to
- Study type: Observational
- Participants enrolled: 114
- From 7 Jul 2022 to the primary completion date, 16 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- No one with a concurrent cancer except those diagnosed with an in situ cancer or non-melanoma skin cancer
Other illness
- Stage IV breast cancer
Other
- Unwilling or unable to give consent
- Unable to participate for 1 year
Who the study is looking for
- All women \> 18 years of age
- Stage I-III breast cancer
- Subject has consented to IRB 2130-00 Tissue Registry
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mayo Clinic in Arizona Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.