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

NCT04239105 | Unknown

• 1 other identifier: Yuan Shifang-1
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Neoplasms; Circulating Tumor Cells

Keywords

Breast Cancer; Circulating Tumor Cells; Microfluidic; Raman Spectrum

Outcome Measures

Primary Outcomes (1)

• The level of CTC markers in breast cancer patients' peripheral blood

  The counts and analysis of CTC of peripheral blood in breast cancer group and healthy control group.

  19 Months

Secondary Outcomes (1)

• The change of CTC markers in breast cancer patients' peripheral blood during chemotherapy and Neoadjuvant chemotherapy

  17 Months

Study Arms (1)

Breast cancer Group

The biopsy result is breast cancer.

Device: Microfluidic and Raman spectrum

Interventions

Microfluidic and Raman spectrum DEVICE

Detection of Circulating Tumor Cells

Breast cancer Group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Breast cancer patients

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead
• Xidian University: collaborator

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MeSH Terms

Conditions

Breast Neoplasms; Neoplastic Cells, Circulating

Interventions

Microfluidics

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rheology; Investigative Techniques; Microtechnology; Miniaturization; Technology; Technology, Industry, and Agriculture

Study Officials

• Shifang Yuan, Ph.D

  Xijing Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shifang Yuan, professor

CONTACT

13991249382; shifangy@fmmu.edu.cn

Bo Hu, professor

CONTACT

18309256226; bohu@xidian.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Vascular and Endocrine Surgery, Xijing Hospital, The Fourth Military Medical University

Study Record Dates

• First Submitted: December 31, 2019
• First Posted: January 23, 2020
• Study Start: January 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: December 1, 2022
• Last Updated: January 23, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share