Official Title
A Prospective Study of Circulating Tumor DNA Detection in Surveillance for Stage ⅢA Non-small-cell Lung Cancer Patients
Brief Title
Circulating Tumor DNA Detection in Surveillance of Surgical Lung Cancer Patients
Protocol ID
NCT02696525
Lead Sponsor
Peking University People's Hospital
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.
Enrollment Count
145 participants
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
Filters
Carcinoma
Non-small-cell Lung Cancer
Lung Neoplasms
UNKNOWN
ADULT
OLDER_ADULT