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

January 19, 2020 updated by: Yuan Shifang, Xijing Hospital

Detection and Analysis of Circulating Tumor Cells (CTCs) in Patients With Breast Cancer Using a Novel Microfluidic and Raman Spectrum Device

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Breast cancer patients

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
19 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
17 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Collaborators

Xidian University

Investigators

  • Principal Investigator: Shifang Yuan, Ph.D, Xijing Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2020

Primary Completion (Anticipated)

July 1, 2021

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

December 31, 2019

First Submitted That Met QC Criteria

January 19, 2020

First Posted (Actual)

January 23, 2020

Study Record Updates

Last Update Posted (Actual)

January 23, 2020

Last Update Submitted That Met QC Criteria

January 19, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Yuan Shifang-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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