Multiplex Analysis of Circulating Tumor DNA

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03301961

Enrollment

400

Registered

2017-10-04

Start date

2019-04-11

Completion date

2022-06-01

Last updated

2020-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Lung Neoplasm, Non-small-cell Lung Cancer

Keywords

Circulating Tumor DNA, Early diagnosis, Surveillance, Methylation, Somatic mutation

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

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

Secondary

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

Countries

China

Contacts

Primary ContactKezhong Chen, MD

mdkzchen@163.com（+86）13488752289

Backup ContactHeng Zhao, MD

zhaohengzhaoheng@126.com（+86）13683139396

Outcome results