NCT04218188

Brief Summary

Biomaterial-based cell culture models have been gaining increasing attention as potential therapeutic strategies. The purpose of this project is to evaluate whether the cell detachment ratio on pH-responsive chitosan could be correlated with the overall survival in lung cancer patients. Through controllable cell-material interaction, this project has the intention to develop an alternative tool for both early diagnosis and accurate prognosis in cancer therapeutics.

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
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

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

First Submitted

Initial submission to the registry

December 17, 2019

Completed
19 days until next milestone

Study Start

First participant enrolled

January 5, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

January 14, 2020

Status Verified

December 1, 2019

Enrollment Period

11 months

First QC Date

December 17, 2019

Last Update Submit

January 12, 2020

Conditions

Keywords

pH-responsive chitosanCancer stem-like cellCell detachment ratioPrognostic factor

Outcome Measures

Primary Outcomes (1)

  • The correlation between the cell detachment ratio and the overall survival

    The purpose of this project is to evaluate whether the cell detachment ratio on pH-responsive chitosan could be correlated with the overall survival in lung cancer patients, hence serve as a prognostic factor for therapeutic strategies. The patient's information required for meta-analysis will be retrieved from medical records, and the log-term follow-up will be conducted.

    5-year follow-up after tumor resection

Secondary Outcomes (1)

  • The analyses of the detached cells by specific markers

    About one week

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

At the discretion of the professional attending physician, the lung cancer patients who need to undergo resection of lung lesions.

You may qualify if:

  • Lung cancer patient between 20-70 years old who need surgery for the resection of lung lesions.
  • 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, Ph.D.

    Department of Biomedical Engineering, National Taiwan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ke-Cheng Chen, M.D., Ph.D.

CONTACT

Chia-Hsiang Yen, PhD student

CONTACT

Study Design

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

Study Record Dates

First Submitted

December 17, 2019

First Posted

January 6, 2020

Study Start

January 5, 2020

Primary Completion

November 17, 2020

Study Completion

December 1, 2022

Last Updated

January 14, 2020

Record last verified: 2019-12

Locations