- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03002350
Clinical Relevance of NGS Analysis for High-purity CTC From Cancer Patients With Disruptive Gene Mutation(s)
Clinical Relevance of Next-generation Sequencing Analysis for High-purity Circulating Tumor Cells From Cancer Patients With Disruptive Gene Mutation(s)
Study Overview
Status
Conditions
Detailed Description
(A) Establish a High-purity isolation of CTCs to NGS platform within one year
(B) Design a Prospective trial (CTCNGS01 at www.clinicaltrials.gov) utilizing the developed technique to elucidate the baseline CTC-NGS information to cancer tissue NGS.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
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Taoyuan, Taiwan, 333
- Recruiting
- Chang Gung Memorial Hospital
-
Contact:
- Yo-Ting Hsueh
- Phone Number: 3703 03-3196200
- Email: sally6869@cgmh.org.tw
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Sub-Investigator:
- Tzu-Chen Yen, M.D
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Sub-Investigator:
- Hung-Chih Hsu, M.D
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
I. Age at diagnosis ≥ 20 years, II. Can fully understand the purpose of the study, pros/cons of entering the trial with clear and free mind III. With acceptable laboratory data for receiving anti-cancer therapy, adjusted by clinicians.
IV. Accept all the protocol procedures, including blood sampling and cancer tissue retrieve.
Exclusion Criteria:
I. Refuse to any of study protocol or procedure(s) at any time before or during the trial.
II. Patients without actionable gene alteration or mutation(s) in tissue at screening phase III. Patients who cannot tolerate anti-cancer therapy for at least 2 months should be withdrawn IV. Patients who cannot cooperate the imaging study for response evaluation of anti-cancer therapy V. Patients' tissue is too small to retrieve for NGS analysis. VI. Difficult blood sampling. VII. Clinician's judgement.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival
Time Frame: one year
|
Measure response or progression events via all available imaging studies, including Chest-Xray, CT scans, or MRI, Positron Emission Tomography(PET)study.
The relationship between CTCs number and time from CTCs checkpoint to disease progression will be analyzed.
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: one year
|
All causes of death would be documented and the relationship between CTCs number and time from CTCs checkpoint to death will be analyzed.
|
one year
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTCNGS001
- MOST-105-2314-B-182A-030 - (Other Identifier: Grantor or Funder MOST-105-2314-B-182A-030 -)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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