- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03301961
Multiplex Analysis of Circulating Tumor DNA
The Clinical Applications of Multiplex Analysis of Circulating Tumor DNA Biomarkers in Lung Cancer Patients
Study Overview
Status
Conditions
Detailed Description
Non-small cell lung cancer (NSCLC) constitutes about 85% of all newly diagnosed cases of lung cancer and continues to be the leading cause of cancer-related deaths worldwide.Early diagnosis and monitoring tumor recurrence after surgery are still far from satisfying.
Circulating tumor DNA(ctDNA) detection has been proved to be feasible in early stage NSCLC in previous studies.Both genomic mutation and methylation a promising biomarker.Therefore,this study will perform multiplex detection of ctDNA,analysing mutations, methylation and other biomarkers,focusing on the early diagnosis and postoperative surveillance for NSCLC patients.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100044
- Recruiting
- Peking University People's Hospital
-
Contact:
- Kezhong Chen, M.D.
- Phone Number: +8613488752289
- Email: mdkzchen@163.com
-
Principal Investigator:
- Jun Wang, M.D.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Sign informed consent and consent to participate in this study;
- Found small nodules in pulmonary by CT and prepare for surgery;
Exclusion Criteria:
- Malignant tumor history within the past 5 years;
- Receiving chemotherapy, radiotherapy or targeted therapy before surgery;
- No matching tissue or blood samplesUnqualified blood samples
- Lesion is pure ground glass opacity.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The sensitivity and specificity of multiplex peripheral blood ctDNA biomarkers in the diagnosis of non-small cell lung cancer
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Comparing the sensitivity and specificity of each peripheral blood biomarkers for the diagnosis of non-small cell lung cancer
Time Frame: 12 months
|
12 months
|
The sensitivity and specificity of multiplex peripheral blood ctDNA biomarkers for tumor relapse detection
Time Frame: 36 months
|
36 months
|
Lead time of tumor relapse detection by multiplex ctDNA biomarkers than radiographic approaches
Time Frame: 36 months
|
36 months
|
Collaborators and Investigators
Investigators
- Study Director: Kezhong Chen, MD, Peking University People's Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PTHO1701
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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