Culture System for Isolating Circulating Tumor cells_2

Diagnostic Techniques and Procedures Clinical Trial

Official title:

Culture System for Isolating Circulating Tumor Cells

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04125667
• Other study ID #: 2019071239RINB
• Status: Recruiting
• Start date: October 31, 2019
• Est. completion date: August 31, 2020

Study information

• Verified date: September 2019
• Source: National Taiwan University Hospital
• Contact: Tai-Horng Young
• Phone: 886-2-23123456
• Email: thyoung[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diagnostic Techniques and Procedures
• Early Diagnosis
• Neoplastic Cells, Circulating

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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