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NCT05945290 · ClinicalTrials.gov registry record
Pre-analytical Factors Affecting ctDNA Analysis in Early and Locally Advanced Breast Cancer
A clinical trial, sponsored by Mayo Clinic.
- Completed
- Registry status
- 114
- Enrollment target
NCT05945290: Completed study, sponsored by Mayo Clinic.
NCT05945290 is a clinical trial that has completed, run by Mayo Clinic. The registered enrollment target is 114 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05945290 has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- 114 participants
- Enrollment target
Study 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.
Primary Outcome
Will be measured as tumor fraction (%), using TARgeted DIgital Sequencing (TARDIS).
Interventions
- PROCEDURE Biospecimen Collection
- OTHER Electronic Health Record Review
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 114 participants |
| Start Date | 2022-07-07 |
| Est. Completion | 2025-06-16 |
What the finished NCT05945290 record still lists
NCT05945290 is an observational study that tracks outcomes without assigning an intervention. The registered 114 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 2 interventions - of which Biospecimen Collection is the first listed.
NCT05945290 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05945290 about?
NCT05945290 is a clinical study titled "Pre-analytical Factors Affecting ctDNA Analysis in Early and Locally Advanced Breast Cancer". 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-ana...
What is the current status of trial NCT05945290?
This trial is currently completed. The enrollment target is 114 participants. The study started on 2022-07-07. Estimated completion is 2025-06-16.
What interventions are being tested in trial NCT05945290?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Electronic Health Record Review (OTHER).
Who is sponsoring clinical trial NCT05945290?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
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