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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03843450
Other study ID # 201811053RINA
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 29, 2019
Est. completion date September 26, 2022

Study information

Verified date September 2020
Source National Taiwan University Hospital
Contact Tai-Horng Young
Phone 23123456
Email thyoung@ntu.edu.tw
Is FDA regulated No
Health authority
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 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date September 26, 2022
Est. primary completion date July 1, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years to 70 Years
Eligibility 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 Design


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 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
Primary 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
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