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). (MEDAL)

A Prospective Study of Longitudinal Monitoring in Surgical Lung Cancer Patients by Circulating Tumor DNA and Its Methylation

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

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Recruiting
      • Peking University People's Hospital
      • Contact: Kezhong Chen, M.D.; Phone Number: +8613488752289; Email: mdkzchen@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Histologically confirmed lung cancer patients who received surgical therapy

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
The concordance of ctDNA genomic and methylation status alterations detected in peripheral blood samples with those in matched tumor samples.	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.	1 year
The variation of aberrant methylated ctDNA concentration before surgery, 3 days after surgery and 1 month after surgery.		1 year
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

Collaborators and Investigators

• Sponsor: Peking University People's Hospital

Publications and helpful links

General Publications

• Kang G, Chen K, Yang F, Chuai S, Zhao H, Zhang K, Li B, Zhang Z, Wang J. Monitoring of circulating tumor DNA and its aberrant methylation in the surveillance of surgical lung Cancer patients: protocol for a prospective observational study. BMC Cancer. 2019 Jun 13;19(1):579. doi: 10.1186/s12885-019-5751-9.

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2018
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: August 5, 2018
• First Submitted That Met QC Criteria: August 14, 2018
• First Posted (Actual): August 17, 2018

Study Record Updates

• Last Update Posted (Actual): June 26, 2020
• Last Update Submitted That Met QC Criteria: June 24, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: lung cancer; surveillance; ctDNA methylation; circulating tumor DNA
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: PTHO1802

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No