Circulating Tumor DNA Detection in Surveillance of Surgical Lung Cancer Patients

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

• Registration Number: 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.

Study Timeline

• Study First Submitted: 2016-02-25
• Study First Submitted QC: 2016-02-25
• Study First Posted: 2016-03-02
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-17
• Last Update Posted: 2018-05-21
• Study Start: 2018-12
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 145

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Lead time of tumor relapse detection by blood or urine circulation tumor DNA than radiographic approaches	4 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Jiang Su Cancer Hospital; 🇨🇳 Nanjing, Jiangsu, China

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China

Guang Dong General Hospital, Thoracic Surgery; 🇨🇳 Guangzhou, Guangdong, China