Clinical Decision-MakingNCT04218188
Evaluation of the Cell Detachment Ratio on pH-responsive Chitosan as a Prognostic Factor in Lung Cancer
An observational study of Clinical Decision-Making and Early Detection of Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Clinical Decision-Making, Early Detection of Cancer
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Jan 2020to 1 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: At the discretion of the professional attending physician, the lung cancer patients who need to undergo resection of lung lesions.
Who may be able to join
- 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.
Who cannot join
- Vulnerable subjects included minors, prisoners, aborigines, pregnant women, people with mental disorders, students, and subordinates, etc.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Yin-Tzu Chen, master
About this study
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.
- Keywords
- pH-responsive chitosan, Cancer stem-like cell, Cell detachment ratio, Prognostic factor
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5-year follow-up after tumor resection
Secondary outcomes (1)
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.
Measured: About one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start5 Jan 2020
- Primary completion17 Nov 2020 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Decision-MakingStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tai-Horng Young, Ph.D., Principal investigator, Department of Biomedical Engineering, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04218188
- Sponsor's protocol ID
- 201910061RINA
- Status last verified
- Dec 2019
- First submitted
- 17 Dec 2019
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Cell Detachment Ratio on pH-responsive Chitosan as a Prognostic Factor in Lung Cancer
- ClinicalTrials.gov ID
- NCT04218188
- Acronym / sponsor ID
- 201910061RINA
- Keywords
- pH-responsive chitosan, Cancer stem-like cell, Cell detachment ratio, Prognostic factor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 5 Jan 2020 (actual)
- Primary completion
- 17 Nov 2020 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 6 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- At the discretion of the professional attending physician, the lung cancer patients who need to undergo resection of lung lesions.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Vulnerable subjects included minors, prisoners, aborigines, pregnant women, people with mental disorders, students, and subordinates, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The correlation between the cell detachment ratio and the overall survival
Time frame: 5-year follow-up after tumor resection
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.
1 secondary outcome
The analyses of the detached cells by specific markers
Time frame: About one week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tai-Horng Young, Ph.D. principal investigator
Department of Biomedical Engineering, National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clinical Decision-Making and Early Detection of Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ke-Cheng Chen, M.D., Ph.D. (886-2-2312-3456 ext. 63408, cskchen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The correlation between the cell detachment ratio and the overall survival (time frame: 5-year follow-up after tumor resection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2020.