Urinary Circulating Tumor DNA Detection in Non-small Cell Lung Cancer: a Prospective Study

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

• Registration Number: NCT02907606
• Lead Sponsor: Peking University People's Hospital

Brief Summary

This study will evaluate the feasibility and effectiveness of urinary ctDNA detection and dynamic monitoring during treatment of NSCLC patients prospectively,by collecting and detecting tumor tissues, peripheral blood samples and urine samples of NSCLC patients.

Detailed Description

Liquid biopsy, specifically through the assessment of circulating tumor DNA(ctDNA) from peripheral blood, has shown great promise in lung cancer diagnosis and therapeutic monitoring.

Urinary samples are completely non-invasive and easily obtainable compared to blood and tissue extraction. To date, only a limited number of published studies have examined the feasibility of ctDNA detection from urine.

This study will collect tumor tissues, pretreatment peripheral blood samples and urine samples from different TNM stages of NSCLC patients, and detect EGFR gene mutations in paired samples.

Study Timeline

• Status Verified: 2016-09
• Study Start: 2016-09
• Study First Submitted: 2016-09-08
• Study First Submitted QC: 2016-09-14
• Last Update Submitted: 2016-09-14
• Study First Posted: 2016-09-20
• Last Update Posted: 2016-09-20
• Primary Completion: 2017-06
• Study Completion: 2020-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Aged 18 to 80 years
• Histologically confirmed diagnosis of stage non-small cell lung cancer undergoing surgical resection
• Completed and explicit information about TNM staging
• Paired specimens including tumor tissues, and both peripheral blood samples and urinary samples before and after surgery.
• Patients must have given written informed consent

Exclusion Criteria

• Unable to comply with the study procedure
• Malignant tumor history within the past 5 years
• Coexisting small cell lung cancer
• Unqualified tissue, blood or urine samples

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The concordant frequency of genomic results among tumor tissue DNA, urinary ctDNA and peripheral blood ctDNA.	12 months

Secondary Outcome Measures

Name	Time	Method
Urinary ctDNA predictive value for locoregional recurrence and distant metastasis.	3 years
Correlation of urine ctDNA concentration preoperative,intraoperative and 3 days after surgery with clinical features and prognosis.	18 months
Lead time of tumor relapse detection by urine ctDNA than tumor markers and radiographic approaches.	3 years
The difference of urine ctDNA detection effectiveness between different TNM stages NSCLC patients.	18 months

Trial Locations

Locations (1)

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