Multiplex Analysis of Circulating Tumor DNA

Carcinoma Clinical Trial

Official title:

The Clinical Applications of Multiplex Analysis of Circulating Tumor DNA Biomarkers in Lung Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03301961
• Other study ID #: PTHO1701
• Status: Recruiting
• Start date: April 11, 2019
• Est. completion date: June 1, 2022

Study information

• Verified date: February 2020
• Source: Peking University People's Hospital
• Contact: Kezhong Chen, MD
• Phone: (+86)13488752289
• Email: mdkzchen[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Lung Neoplasm
• Lung Neoplasms
• Non-small-cell Lung Cancer

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The sensitivity and specificity of multiplex peripheral blood ctDNA biomarkers in the diagnosis of non-small cell lung cancer		12 months
Secondary	Comparing the sensitivity and specificity of each peripheral blood biomarkers for the diagnosis of non-small cell lung cancer		12 months
Secondary	The sensitivity and specificity of multiplex peripheral blood ctDNA biomarkers for tumor relapse detection		36 months
Secondary	Lead time of tumor relapse detection by multiplex ctDNA biomarkers than radiographic approaches		36 months