NCT03843450

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 29, 2019

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 18, 2019

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2022

Completed
Last Updated

November 5, 2020

Status Verified

September 1, 2020

Enrollment Period

3.4 years

First QC Date

February 14, 2019

Last Update Submit

November 4, 2020

Conditions

Keywords

circulating tumor cells,WBCs adhesion, biomedical materials

Outcome Measures

Primary Outcomes (2)

  • 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

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Study Officials

  • Tai-Horng Young

    Institute of Biomedical Engineering, National Taiwan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tai-Horng Young

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2019

First Posted

February 18, 2019

Study Start

January 29, 2019

Primary Completion

July 1, 2022

Study Completion

September 26, 2022

Last Updated

November 5, 2020

Record last verified: 2020-09

Locations