Circulating Tumor DNA Detection in Surveillance of Surgical Lung Cancer Patients

Peking University

Status: Unknown

Conditions: Lung Neoplasms; Carcinoma; Non-small-cell Lung Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT02696525

PTHO1601

Details and patient eligibility

About

Conduct a prospective study to confirm blood and urine ctDNA detection value in non-small-cell lung cancer patients.

Full 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: 145 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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