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 cancer 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 Detection of Cancer

• Study Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

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 polycythemia patients between the ages of 20 and 70. We just use the waste blood from patients' routine phlebotomy therapy. 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:

1. Polycythemia patients are between the ages of 20 and 70.
2. Willing to sign the consent form under the informed consent.

Inclusion Criteria:

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cancer Cell Isolation Efficiency of The Isolation System	The percentage isolation of fluorescently-labeled A549 cell lines will be spiked into the whole blood, and the put into the system. The supernatant of the system will be collected to re-culture on the culture dishes and analyzed by fluorescence microscope.	1 day
WBCs adhesion ratio	The whole blood will be diluted and put into the system. And the supernatant will be collected to count the number of blood cell number by the automatic blood cell count.	1 hour

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2019
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): September 26, 2022

Study Registration Dates

• First Submitted: February 14, 2019
• First Submitted That Met QC Criteria: February 14, 2019
• First Posted (Actual): February 18, 2019

Study Record Updates

• Last Update Posted (Actual): November 5, 2020
• Last Update Submitted That Met QC Criteria: November 4, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: circulating tumor cells,WBCs adhesion, biomedical materials
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis; Neoplastic Cells, Circulating
• Other Study ID Numbers: 201811053RINA