Culture System for Isolating Circulating Tumor cells_2

Culture System for Isolating Circulating Tumor Cells

This culture system utilizes the special affinity difference of biomedical material coating for different cells to achieve the effect of isolating tumor cells from the blood sample. The coating of the system has the characteristic that to make the WBCs adhesion, but the cancer cells in the blood sample suspend in the culture medium, which achieves the effect of separating cancer cells from the blood. The supernatant with the cancer cells can further be isolated from the cultural system for related analysis and detection to achieve early diagnosis and screening.

Study Overview

• Status: Unknown
• Conditions: Early Diagnosis; Diagnostic Techniques and Procedures

• Study Type: Observational
• Enrollment (Anticipated): 45

Contacts and Locations

• Study Contact: Name: Yin-Tzu Chen; Phone Number: 81455 886-2-23123456; Email: R07528032@ntu.edu.tw
• Study Contact Backup: Name: Tai-Horng Young; Phone Number: 81455 886-2-23123456; Email: thyoung@ntu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Yin-Tzu Chen; Phone Number: 81455 886-2-23123456; Email: R07528032@ntu.edu.tw
    • Contact: Tai-Horng Young; Phone Number: 81455 886-2-23123456; Email: thyoung@ntu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will include all stages of lung cancer patients between the ages of 20 and 70. Also, to protect the vulnerable subjects, we don't recruit minors, prisoners, aborigines, pregnant women, people with mental disorders, students, and subordinates, etc.

Description

Inclusion Criteria:

• Patients with lung cancer are between the ages of 20 and 70
• Willing to sign the consent form under the informed consent

Exclusion Criteria:

• Vulnerable Subjects included minors, prisoners, aborigines, pregnant women, people with mental disorders, students, and subordinates, etc.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Number of Circulating Cancer Cells from The Blood Sample	The number of circulating cancer cells from the blood sample will be investigated. To distinguish cancer cells from blood cells for the system, the lung cancer cells were immunofluorescence stained for Cytokeratin, white blood cells were stained for CD45 and nuclei were counterstained with DAPI.	about 1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cancer Cell Isolation Efficiency of The Isolation System	The cell isolation efficiency was characterized by spiking A549 lung cancer cells with celltracker at the concentrations 1000, 100 and 10 cells into whole blood.	about 1 week

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Study Chair: Tai-Horng Young, Institute of Biomedical Engineering, National Taiwan University

Study record dates

Study Major Dates

• Study Start (Anticipated): October 31, 2019
• Primary Completion (Anticipated): August 31, 2020
• Study Completion (Anticipated): August 31, 2020

Study Registration Dates

• First Submitted: October 2, 2019
• First Submitted That Met QC Criteria: October 10, 2019
• First Posted (Actual): October 14, 2019

Study Record Updates

• Last Update Posted (Actual): October 14, 2019
• Last Update Submitted That Met QC Criteria: October 10, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Circulating cancer cells; Biomedical polymer material; Cell affinity difference; White blood cell attachment
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis; Neoplastic Cells, Circulating
• Other Study ID Numbers: 2019071239RINB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No