Carcinoma, Lung Neoplasms, Non-small-cell Lung Cancer
Conditions
Keywords
Non-small-cell Lung Cancer, circulating tumor DNA, urine
Brief summary
This study will evaluate the feasibility and effectiveness of urinary ctDNA detection and dynamic monitoring during treatment of NSCLC patients prospectively,by collecting and detecting tumor tissues, peripheral blood samples and urine samples of NSCLC patients.
Detailed description
Liquid biopsy, specifically through the assessment of circulating tumor DNA(ctDNA) from peripheral blood, has shown great promise in lung cancer diagnosis and therapeutic monitoring. Urinary samples are completely non-invasive and easily obtainable compared to blood and tissue extraction. To date, only a limited number of published studies have examined the feasibility of ctDNA detection from urine. This study will collect tumor tissues, pretreatment peripheral blood samples and urine samples from different TNM stages of NSCLC patients, and detect EGFR gene mutations in paired samples.
Interventions
None listed
Sponsors
San Valley Biotechnology Incorporated
Peking University People's Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Aged 18 to 80 years * Histologically confirmed diagnosis of stage non-small cell lung cancer undergoing surgical resection * Completed and explicit information about TNM staging * Paired specimens including tumor tissues, and both peripheral blood samples and urinary samples before and after surgery. * Patients must have given written informed consent
Exclusion criteria
* Unable to comply with the study procedure * Malignant tumor history within the past 5 years * Coexisting small cell lung cancer * Unqualified tissue, blood or urine samples
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The concordant frequency of genomic results among tumor tissue DNA, urinary ctDNA and peripheral blood ctDNA. | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| The difference of urine ctDNA detection effectiveness between different TNM stages NSCLC patients. | 18 months |
| Urinary ctDNA predictive value for locoregional recurrence and distant metastasis. | 3 years |
| Correlation of urine ctDNA concentration preoperative,intraoperative and 3 days after surgery with clinical features and prognosis. | 18 months |
| Lead time of tumor relapse detection by urine ctDNA than tumor markers and radiographic approaches. | 3 years |
Countries
China
Contacts
Primary ContactXiao Li, M.D
Outcome results
None listed