Clinical trial · Observational
Detecting Circulating Tumor Cells (CTCs) and Cell Free DNA (cfDNA) in Peripheral Blood of Breast Cancer (BC) Patients to Develop the Clinical Application for Early Detection and Diagnostics
NCT03511859CI-TRIAL-00032725unknownClinicalTrials.gov clinicaltrialsProvenance
- 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)
Utilization of circulating-tumor-cell (CTC) and cell free DNA (cfDNA) as novel and noninvasive tests for diagnosis confirmation, therapy selection, and cancer surveillance is a rapidly growing area of interest. In the wake of FDA approval of a liquid biopsy test, it is important for clinicians to acknowledge the obvious clinical utility of liquid biopsy for cancer management throughout the course of the disease.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Control Group
- description
- Mammography/ultrasonography confirmed no findings.
- label
- Cancer Group
- description
- The biopsy result is breast cancer.
Primary outcomes (1)
- measure
- The objective of this study is to demonstrate that CTC assay counts can distinguish between healthy subjects and malignant breast cancer subjects, including early stage breast cancer subjects.
- timeFrame
- 3 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * All subjects need to sign the informed consent form and age is above 20. * Control group need to have mammogram /ultrasound results category1-3 and confirmed by PI. * Cancer group subjects with pathology report confirmed to be malignant have not yet done surgery or treatment will be enrolled to the malignant group for analysis Exclusion Criteria: * Not willing to sign the informed consent form * Have been undergone general anesthesia or regional anesthesia in 1 month * Have been diagnosed with any type of cancer and been treated * Have been suffering from autoimmune disorder such as SLE and RA * Have been suffering from chronic infection such as IBD, pancreatitis, COPD or Interstitial pneumonia. * Have been suffering from acute infection or other infectious diseases in 3 moths such as TB, pneumonia, urinary tract infection, or cellular infection * Diagnosed with myelodysplastic syndrome or myeloproliferative diseases * Other condition which may affect the CTC results, when determined by PI can be confirmed by other tests are if necessary
References
Publications (0)
Data not yet available
No reference posted for this study.