Multiplex Analysis of Circulating Tumor DNA

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

• Registration Number: NCT03301961
• Lead Sponsor: Peking University People's Hospital

Brief Summary

Lung cancer is the leading cause of cancer-related death in China. This study will explore the applications of multiplex analysis of circulating tumor DNA biomarkers for diagnosis and surveillance of lung cancer patients

Detailed Description

Non-small cell lung cancer (NSCLC) constitutes about 85% of all newly diagnosed cases of lung cancer and continues to be the leading cause of cancer-related deaths worldwide.Early diagnosis and monitoring tumor recurrence after surgery are still far from satisfying.

Circulating tumor DNA(ctDNA) detection has been proved to be feasible in early stage NSCLC in previous studies.Both genomic mutation and methylation a promising biomarker.Therefore,this study will perform multiplex detection of ctDNA,analysing mutations, methylation and other biomarkers,focusing on the early diagnosis and postoperative surveillance for NSCLC patients.

Study Timeline

• Study First Submitted: 2017-09-30
• Study First Submitted QC: 2017-09-30
• Study First Posted: 2017-10-04
• Study Start: 2019-04-11
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-04
• Last Update Posted: 2020-02-05
• Primary Completion: 2020-06-01
• Study Completion: 2022-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Sign informed consent and consent to participate in this study;
2. Found small nodules in pulmonary by CT and prepare for surgery;

Exclusion Criteria

1. Malignant tumor history within the past 5 years;
2. Receiving chemotherapy, radiotherapy or targeted therapy before surgery;
3. No matching tissue or blood samplesUnqualified blood samples
4. Lesion is pure ground glass opacity.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The sensitivity and specificity of multiplex peripheral blood ctDNA biomarkers in the diagnosis of non-small cell lung cancer	12 months

Secondary Outcome Measures

Name	Time	Method
Comparing the sensitivity and specificity of each peripheral blood biomarkers for the diagnosis of non-small cell lung cancer	12 months
Lead time of tumor relapse detection by multiplex ctDNA biomarkers than radiographic approaches	36 months
The sensitivity and specificity of multiplex peripheral blood ctDNA biomarkers for tumor relapse detection	36 months

Trial Locations

Locations (1)

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