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Detection of Circulating Tumor Cells in Breast Cancer Patients Using a Novel Microfluidic and Raman Spectrum Device

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ClinicalTrials.gov Identifier: NCT04239105
Recruitment Status : Not yet recruiting
First Posted : January 23, 2020
Last Update Posted : January 23, 2020
Sponsor:
Collaborator:
Xidian University
Information provided by (Responsible Party):
Yuan Shifang, Xijing Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Breast Neoplasms Circulating Tumor Cells Device: Microfluidic and Raman spectrum

Detailed Description:

Circulating tumor cells (CTCs) are a new type of breast cancer molecular marker. 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. At present, there is a great challenge to create an effective platform that can isolate these cells, as they are extremely rare: only 1-10 CTCs are present in a 7.5mL of a cancer patient's peripheral blood. The majority of the CTC capture methods are based on EpCAM expression as a surface marker of tumor-derived cells. However, EpCAM protein expression levels can be significantly down regulated during cancer progression as a consequence of the process of epithelial to mesenchymal transition. Although many technologies have been reported to achieve the capture and counting of CTCs, these methods study little information of cells and limited biological information can be obtained, leading to a lack in clinical diagnosis.

Microfluidics has demonstrated great potential as an effective technique for the medical and biological sciences. Inspired by the bed topography in river meanders, here, the investigators report a novel river meander-like cross-section in helical microchannels for size-based inertial focusing and enrichment, aiming to realize more functional geometries as well as reduce the extensive laborious requirement in traditional fabrication process. This device can facilitate particle focusing at a larger scale than traditional channels. Compared to the circular, rectangular and trapezoidal channels, the river meander-like microfluidic channel can successfully realize 26 μm particle focusing with a thinner focusing band in a shorter channel length. Also, in a single test, this structure can achieve 85.4% recovery and the enrichment ratio of 1.86 of spiked MDA-MB-231 cells in the whole blood, overcoming the dependence on traditional cell manipulation microfluidic devices. These results indicate that this river meander-like microfluidic chip has the great potential of size-based cell/particle sorting and enrichment for clinical application. Meanwhile, Surface-enhanced Raman scattering (SERS) has such advantages as high sensitivity, flexible excitation wavelength, high spectral resolution, non-invasiveness to biological samples, resistance self-fluorescence, photobleaching, etc., which is considered as a promising and powerful real-time detection technology for unlabeled cells. But SERS spectrum of cell contains information about different molecules, so it usually requires complex data interpretation. Therefore, the application of Raman spectroscopy combined with chemometrics in biological problems has attracted more and more attention. However, analysis result of chemometrics can be influenced by the complex background of Raman spectroscopy. Therefore, a pre-processing is needed to remove these influencing factors.

Based on these previous work, the investigators have developed a novel technology for the detection of CTCs of breast cancer. The detection platform constructed by the combination of microfluidic chip and surface-enhanced Raman spectroscopy is used to detect the blood sample of the subject, obtain the high quality of breast cancer circulating tumor cells from the aspects of cell specificity, surface structure and molecular activity of surface-enhanced Raman spectrum information, and extract the characteristics of different breast cancer circulating tumor cells by related signal feature extraction methods, establish a standard surface-enhanced Raman spectral feature database for the main types of breast cancer circulating tumor cells.

This technology aims to build a platform allowing for cell detection, synthesize particles for surface plasmon Raman enhancement, fabricate microfluidic devices, study the collection and analysis of the Raman spectra of CTCs, establish the database of CTC Raman spectra and develop the evaluation method of the biological detection. 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.

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Detection and Analysis of Circulating Tumor Cells (CTCs) in Patients With Breast Cancer Using a Novel Microfluidic and Raman Spectrum Device
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
Breast cancer Group
The biopsy result is breast cancer.
Device: Microfluidic and Raman spectrum
Detection of Circulating Tumor Cells




Primary Outcome Measures :
  1. The level of CTC markers in breast cancer patients' peripheral blood [ Time Frame: 19 Months ]
    The counts and analysis of CTC of peripheral blood in breast cancer group and healthy control group.


Secondary Outcome Measures :
  1. The change of CTC markers in breast cancer patients' peripheral blood during chemotherapy and Neoadjuvant chemotherapy [ Time Frame: 17 Months ]
    The counts and analysis of CTC in patients' peripheral blood during chemotherapy and Neoadjuvant chemotherapy in different periods.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Breast cancer patients
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04239105


Contacts
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Contact: Shifang Yuan, professor 13991249382 shifangy@fmmu.edu.cn
Contact: Bo Hu, professor 18309256226 bohu@xidian.edu.cn

Sponsors and Collaborators
Xijing Hospital
Xidian University
Investigators
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Principal Investigator: Shifang Yuan, Ph.D Xijing Hospital

Publications of Results:
Other Publications:

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Responsible Party: Yuan Shifang, Director of Department of Vascular and Endocrine Surgery, Xijing Hospital, The Fourth Military Medical University, Xijing Hospital
ClinicalTrials.gov Identifier: NCT04239105    
Other Study ID Numbers: Yuan Shifang-1
First Posted: January 23, 2020    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Yuan Shifang, Xijing Hospital:
Breast Cancer
Circulating Tumor Cells
Microfluidic
Raman Spectrum
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplastic Cells, Circulating
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes