NCT04125667

Brief 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.

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
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2019

Shorter than P25 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

First Submitted

Initial submission to the registry

October 2, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 14, 2019

Completed
17 days until next milestone

Study Start

First participant enrolled

October 31, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

October 14, 2019

Status Verified

September 1, 2019

Enrollment Period

10 months

First QC Date

October 2, 2019

Last Update Submit

October 10, 2019

Conditions

Keywords

Circulating cancer cellsBiomedical polymer materialCell affinity differenceWhite blood cell attachment

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Cancer Cell Isolation Efficiency of The Isolation System

    about 1 week

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 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.

You may qualify if:

  • Patients with lung cancer 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

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Tai-Horng Young

    Institute of Biomedical Engineering, National Taiwan University

    STUDY CHAIR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

October 2, 2019

First Posted

October 14, 2019

Study Start

October 31, 2019

Primary Completion

August 31, 2020

Study Completion

August 31, 2020

Last Updated

October 14, 2019

Record last verified: 2019-09

Locations