Evaluation of the Cell Detachment Ratio on pH-responsive Chitosan as a Prognostic Factor in Lung Cancer

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.

Study Overview

• Status: Unknown
• Conditions: Early Detection of Cancer; Clinical Decision-Making

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University Hospital
    • Sub-Investigator: Yin-Tzu Chen, master

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The analyses of the detached cells by specific markers	The isolated and purified patient-derived tumor cells will be characterized by the expression of surface markers using flow cytometry.	About one week

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Tai-Horng Young, Ph.D., Department of Biomedical Engineering, National Taiwan University

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2020
• Primary Completion (Anticipated): November 17, 2020
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: December 17, 2019
• First Submitted That Met QC Criteria: January 2, 2020
• First Posted (Actual): January 6, 2020

Study Record Updates

• Last Update Posted (Actual): January 14, 2020
• Last Update Submitted That Met QC Criteria: January 12, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Prognostic factor; pH-responsive chitosan; Cancer stem-like cell; Cell detachment ratio
• Other Study ID Numbers: 201910061RINA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No