Clinical trial NCT03634826: 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).
Official title: A Prospective Study of Longitudinal Monitoring in Surgical Lung Cancer Patients by Circulating Tumor DNA and Its Methylation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carcinoma
Lung Cancer
NSCLC
Lung Neoplasm
Keywords: circulating tumor DNA
ctDNA methylation
lung cancer
surveillance
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2018-08-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Histologically confirmed lung cancer patients who received surgical therapy

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.

Eligibility criteria: 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

Primary outcomes:
measure: Correlation between patients' recurrence and quantitative detection of circulating tumor DNA (ctDNA) concentration, including the quantitative detection of ctDNA mutations and ctDNA aberrant methylation.
timeFrame: 3 years
Secondary outcomes:
measure: The concordance of ctDNA genomic and methylation status alterations detected in peripheral blood samples with those in matched tumor samples.
timeFrame: 1 year
measure: The variation of aberrant methylated ctDNA concentration before surgery, 3 days after surgery and 1 month after surgery.
timeFrame: 1 year
measure: Correlation between disease free time and quantitative detection of ctDNA genomic alterations or methylation status alterations in patients who receives adjuvant therapy.
timeFrame: 3 years
measure: Leading time of tumor relapse detection by circulating tumor DNA and methylation status than traditional radiological methods.
timeFrame: 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital Thoracic Surgery Department
name: Jun Wang, M.D.
role: STUDY_CHAIR
References:
citation: 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.