Clinical trial · Observational
Detection of Circulating Tumor Cells in Breast Cancer Patients Using a Novel Microfluidic and Raman Spectrum Device
Detection and Analysis of Circulating Tumor Cells (CTCs) in Patients With Breast Cancer Using a Novel Microfluidic and Raman Spectrum Device
- 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)
Circulating tumor cells (CTCs) in peripheral blood originate from breast cancer (primary and metastatic lesions) shedding. Utilization of CTCs as novel and noninvasive tests for diagnosis confirmation, therapy selection, and cancer surveillance is a rapidly growing area of interest. In this project, the investigators will explore a novel detection technology of circulating tumor cells in breast cancer using novel Microfluidic and Raman Spectrum Device. The primary objective is to demonstrate that the CTC assay counts technology can distinguish between healthy subjects and malignant breast cancer subjects. The secondary objective is to demonstrate that the CTCs detection technology can evaluate the efficacy of chemotherapy and neoadjuvant chemotherapy, as well as dynamic treatment monitoring and prognosis evaluation.
Conditions
Conditions (2)
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Circulating Tumor Cells | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Microfluidic and Raman spectrum | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Breast cancer Group
- description
- The biopsy result is breast cancer.
- interventionNames
- Device: Microfluidic and Raman spectrum
Primary outcomes (1)
- measure
- The level of CTC markers in breast cancer patients' peripheral blood
- timeFrame
- 19 Months
- description
- The counts and analysis of CTC of peripheral blood in breast cancer group and healthy control group.
Secondary outcomes (1)
- measure
- The change of CTC markers in breast cancer patients' peripheral blood during chemotherapy and Neoadjuvant chemotherapy
- timeFrame
- 17 Months
- description
- The counts and analysis of CTC in patients' peripheral blood during chemotherapy and Neoadjuvant chemotherapy in different periods.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * All subjects need to sign the informed consent form. * Age of at least 20 and at most 70 years. * Cancer group subjects with pathology report confirmed to be malignant. * Chemotherapy is necessary before or after surgery. * Control group need to have mammogram /ultrasound results category1-3. * Patients must be available for and compliant to treatment and follow-up. Exclusion Criteria: * Not willing to sign the informed consent form. * Pregnant or lactating patients. * Prior or concomitant secondary malignancy. * Any other serious medical pathology, such as congestive heart failure. * Other condition which may affect the CTC results. * Males.
References
Publications (37)
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- BACKGROUNDFan L, Strasser-Weippl K, Li JJ, St Louis J, Finkelstein DM, Yu KD, Chen WQ, Shao ZM, Goss PE. Breast cancer in China. Lancet Oncol. 2014 Jun;15(7):e279-89. doi: 10.1016/S1470-2045(13)70567-9. PMID 24872111
- BACKGROUNDHong Y, Li Z, Zhang Q. A circulating tumor cell cluster-based model for tumor metastasis (Hypothesis). Oncol Lett. 2016 Dec;12(6):4891-4895. doi: 10.3892/ol.2016.5358. Epub 2016 Nov 7. PMID 28105198
- BACKGROUNDMicalizzi DS, Maheswaran S, Haber DA. A conduit to metastasis: circulating tumor cell biology. Genes Dev. 2017 Sep 15;31(18):1827-1840. doi: 10.1101/gad.305805.117. PMID 29051388
- BACKGROUNDAlix-Panabieres C, Mader S, Pantel K. Epithelial-mesenchymal plasticity in circulating tumor cells. J Mol Med (Berl). 2017 Feb;95(2):133-142. doi: 10.1007/s00109-016-1500-6. Epub 2016 Dec 24. PMID 28013389
- BACKGROUNDMittal V. Epithelial Mesenchymal Transition in Tumor Metastasis. Annu Rev Pathol. 2018 Jan 24;13:395-412. doi: 10.1146/annurev-pathol-020117-043854. PMID 29414248
- BACKGROUNDCabel L, Proudhon C, Gortais H, Loirat D, Coussy F, Pierga JY, Bidard FC. Circulating tumor cells: clinical validity and utility. Int J Clin Oncol. 2017 Jun;22(3):421-430. doi: 10.1007/s10147-017-1105-2. Epub 2017 Feb 25. PMID 28238187
- BACKGROUNDAlix-Panabieres C, Pantel K. Clinical Applications of Circulating Tumor Cells and Circulating Tumor DNA as Liquid Biopsy. Cancer Discov. 2016 May;6(5):479-91. doi: 10.1158/2159-8290.CD-15-1483. Epub 2016 Mar 11.