A Prospective Study of Circulating Tumor DNA Detection in Surveillance for Stage ⅢA Non-small-cell Lung Cancer Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Carcinoma
- Sponsor
- Peking University People's Hospital
- Enrollment
- 145
- Locations
- 3
- Primary Endpoint
- Lead time of tumor relapse detection by blood or urine circulation tumor DNA than radiographic approaches
- Last Updated
- 7 years ago
Overview
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.
Investigators
Jun Wang
Chief，Thoracic Surgery Service
Peking University People's Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
Lead time of tumor relapse detection by blood or urine circulation tumor DNA than radiographic approaches
Time Frame: 4 years
Secondary Outcomes
- 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)