Carcinoma, Lung Neoplasms, Non-small-cell Lung Cancer
Conditions
Keywords
Circulating Tumor DNA, Lung cancer, lead time
Brief summary
Conduct a prospective study to confirm blood and urine ctDNA detection value in non-small-cell lung cancer patients.
Detailed description
Studies have shown the feasibility of detecting mutation status by blood and urine circulating tumor DNA (ctDNA)in non-small cell lung cancer (NSCLC) patients. However, no prospective has been conducted for usage of ctDNA in postoperative surveillance of NSCLC patients. We plan to compare tumor makers and radiographic approaches with blood and urine ctDNA in surveillance to assess the lead time of postoperative tumor relapse in stage ⅢA NSCLC patients. And evaluate the correlation between ctDNA level with tumor relapse or metastasis.
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 * Undergo radical surgery（R0 resection） * Histologically confirmed diagnosis of stage ⅢA non-small cell lung cancer * Positive Driver mutation(EGFR、PTEN、PIK3CA、BRAF、K-RAS、Her2) in tumor tissue * Blood or urine circulating tumor detect the driver mutation detected in tumor tissue * Patients must have given written informed consent
Exclusion criteria
* Unable to comply with the study procedure * Malignant tumor history within the past 5 years * Patients who received any treatment prior to resection * R1 or R2 resection * Coexisting small cell lung cancer * Received target drug therapy after surgery * Unqualified blood or urine samples
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lead time of tumor relapse detection by blood or urine circulation tumor DNA than radiographic approaches | 4 years |
Secondary
| Measure | Time frame |
|---|---|
| Lead time of tumor relapse detection by blood or urine circulation tumor DNA than tumor markers | 4 years |
| The concordance of ctDNA genomic alterations detection in peripheral blood and urine with those in matched tumor sample | 1 year |
| Correlation of blood and urine ctDNA concentration before surgery with clinical features and prognosis | 4 years |
| Correlation of blood and urine ctDNA concentration 3 days after surgery with clinical features and prognosis | 4 years |
| CtDNA predictive value between locoregional recurrence and distant metastasis | 4 years |
Countries
China
Contacts
Primary ContactKezhong Chen, M.D.
Backup ContactLixin Zhou, M.D.
Outcome results
None listed