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

Early Detection of Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04218188
• Other study ID #: 201910061RINA
• Status: Recruiting
• Start date: January 5, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: December 2019
• Source: National Taiwan University Hospital
• Contact: Ke-Cheng Chen, M.D., Ph.D.
• Phone: 886-2-2312-3456
• Email: cskchen[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 1, 2022
• Est. primary completion date: November 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Clinical Decision-Making
• Early Detection of Cancer

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	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	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