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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
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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Mayo Clinic in Arizona
Coordinator of this site? Confirm its status
ScottsdaleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.