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).

Lung Cancer Clinical Trial

— MEDAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03634826
• Other study ID #: PTHO1802
• Status: Recruiting
• Start date: August 15, 2018
• Est. completion date: January 1, 2022

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 1, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Lung Cancer
• Lung Neoplasm
• Lung Neoplasms
• NSCLC

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	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	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
Secondary	The variation of aberrant methylated ctDNA concentration before surgery, 3 days after surgery and 1 month after surgery.		1 year
Secondary	Correlation between disease free time and quantitative detection of ctDNA genomic alterations or methylation status alterations in patients who receives adjuvant therapy.		3 years
Secondary	Leading time of tumor relapse detection by circulating tumor DNA and methylation status than traditional radiological methods.		3 years