Non-Invasive ctDNA Methylation Detection for Lung Nodule Patients

• Conditions: Lung Nodule

• Registration Number: NCT03685669
• Lead Sponsor: Shanghai Chest Hospital

Brief Summary

Low-dose computed tomography (LDCT) is recommended for early-stage lung cancer screening. However, it is often difficult to determine indolent lesions from more aggressive tumors without an invasive intervention or prolonged follow-up period. Thus, the main purpose of this study is to develop a non-invasive method to detect lung-cancer specific circulating tumor DNA (ctDNA) in blood, which can greatly improve the specificity of lung cancer early screening.

Detailed Description

In this study, the investigators sought to explore sensitive and specific methylation biomarkers that are highly prevalent in lung cancer. It is the first time to perform screening assay on healthy, lung nodule, and lung cancer tissues to identify preliminary set of highly prevalent methylation markers, and then refined these markers by removing regions were unstable in matched plasma samples. Next, investigators interrogated significant methylation marker regions enriched in lung nodules of training sample set to buildup a non-invasive biomarker classification model to discriminate cancerous nodules from benign lesions. Eventually, the model in patient lung nodule samples were validated.

Study Timeline

• Study Start: 2017-06-01
• Status Verified: 2018-09
• Study First Submitted: 2018-09-10
• Study First Submitted QC: 2018-09-24
• Study First Posted: 2018-09-26
• Last Update Submitted: 2019-01-20
• Last Update Posted: 2019-01-23
• Primary Completion: 2019-06
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. 18 years old or above with pulmonary nodule(s) found by LDCT, mean diameter below 30mm.
2. The nodule lesion is peripheral, no signs of lymphatic infiltration or distal metastasis.
3. Fit and consent to surgical resection.
4. Agree to participate in this study and sign informed consents.

Exclusion Criteria

1. Fail to understand or agree to sign informed consent.
2. Patients who did not follow the test plan for timely blood collection or did not cooperate with the study follow-up work.
3. Patients with previous history of cancer and/or cancer treatment such as surgery, radiotherapy, chemotherapy or targeted therapy.
4. Failing to meet the requirements for blood sampling.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Noninvasive assisted diagnosis of benign and malignant pulmonary nodules	1 year	The biomarker classification model can be used to differentiate patients, who had positive LDCT results, with benign or malignant lung nodules.

Trial Locations

Locations (1)

Shanghai Chest Hospital; 🇨🇳 Shanghai, Shanghai, China