Clinical trial · Observational
Pre-analytical Factors Affecting ctDNA Analysis in Early and Locally Advanced Breast Cancer
Pre-Analytical Factors Affecting ctDNA Analysis in Early and Locally Advanced Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anatomic Stage I Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage II Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage III Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Early Stage Breast Carcinoma | Early Stage Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Locally Advanced Breast Carcinoma | Breast Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Electronic Health Record Review | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observational (Biospecimen collection, medical record)
- description
- Patients undergo blood sample collection throughout the study. Patients also undergo collection of leftover tissue samples from SOC procedures and have medical records reviewed.
- interventionNames
- Procedure: Biospecimen Collection
- Other: Electronic Health Record Review
Primary outcomes (1)
- measure
- Change in tumor specific circulating tumor deoxyribonucleic acid (ctDNA) levels
- timeFrame
- Baseline to 5 years
- description
- Will be measured as tumor fraction (%), using TARgeted DIgital Sequencing (TARDIS).
Secondary outcomes (4)
- measure
- Change in total cell-free DNA concentration
- timeFrame
- Baseline to 5 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available