Monitoring of Circulating Tumor DNA and Its Aberrant Methylation in the Surveillance of Surgical Lung Cancer Patients (MEDAL, MEthylation Based Dynamic Analysis for Lung Cancer).

• Conditions: NSCLC; Lung Neoplasm; Carcinoma; Lung Cancer

• Registration Number: NCT03634826
• Lead Sponsor: Peking University People's Hospital

Brief Summary

Conduct a prospective study to confirm the value of circulating tumor DNA and its aberrant methylation in longitudinal monitoring of surgical lung cancer patients.

Detailed Description

Studies have already demonstrated the feasibility of circulating tumor DNA as a surrogate to reveal tumor mutation status in lung cancer patients and a few researches have shown the potential ability of using circulating tumor DNA in surveillance. However, no study focused on the value of methylation status of circulating tumor DNA in the surveillance and no strict prospective study has been performed in surgical lung cancer patients.

The investigators plan to analyze the dynamic change of circulating tumor DNA and its methylation status longitudinally from preoperation to long term follow-up in surgical lung cancer patients, and compare assessment value between circulating tumor DNA detection with methylation , traditional imaging examinations and traditional blood tumor markers in the monitoring process.

Study Timeline

• Study First Submitted: 2018-08-05
• Study First Submitted QC: 2018-08-14
• Study Start: 2018-08-15
• Study First Posted: 2018-08-17
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-24
• Last Update Posted: 2020-06-26
• Primary Completion: 2021-12-31
• Study Completion: 2022-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Aged 18 to 80 years

• Lung cancer was suspected preoperatively.
• Received curative surgical therapy
• No malignant tumor history within the past 5 years
• No being received any treatment prior to resection
• Patients must have given written informed consent

Exclusion Criteria

• The pulmonary nodule is pure ground glass opacity
• Unable to comply with the study procedure
• The postoperative pathology is not NSCLC.
• Unqualified blood samples

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between patients' recurrence and quantitative detection of circulating tumor DNA (ctDNA) concentration, including the quantitative detection of ctDNA mutations and ctDNA aberrant methylation.	3 years

Secondary Outcome Measures

Name	Time	Method
The concordance of ctDNA genomic and methylation status alterations detected in peripheral blood samples with those in matched tumor samples.	1 year	Concordance will be defined as matched ctDNA and tumor DNA has the same identified mutations (methylation status alterations) or has no mutation (methylation status alteration). Concordance rate (%) will be calculated by consistent patient number and total patient number.
Correlation between disease free time and quantitative detection of ctDNA genomic alterations or methylation status alterations in patients who receives adjuvant therapy.	3 years
Leading time of tumor relapse detection by circulating tumor DNA and methylation status than traditional radiological methods.	3 years
The variation of aberrant methylated ctDNA concentration before surgery, 3 days after surgery and 1 month after surgery.	1 year

Trial Locations

Locations (1)

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