Non-Invasive ctDNA Methylation Detection for Lung Nodule Patients

Detection of Early-stage Lung Cancer by Using Methylation Signatures in Circulating Tumor DNA

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.

Study Overview

• Status: Unknown
• Conditions: Lung Nodule

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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Liu Ruijun, MD; Phone Number: 13917200418; Email: iamliuruijun@126.com
• Study Contact Backup: Name: Lu Shun, MD; Phone Number: 18017321551; Email: shun_lu@hotmail.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Recruiting
      • Shanghai Chest Hospital
      • Contact: Ruijun Liu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adult patients who have single or multiple lung nodules detected by LDCT and are about to undergo surgery; healthy sex and age matched controls

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Lung nodule group
Healthy Control group

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai Chest Hospital
• Collaborators: Singlera Genomics Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: September 10, 2018
• First Submitted That Met QC Criteria: September 24, 2018
• First Posted (Actual): September 26, 2018

Study Record Updates

• Last Update Posted (Actual): January 23, 2019
• Last Update Submitted That Met QC Criteria: January 20, 2019
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: ctDNA; DNA methylation
• Other Study ID Numbers: KS1811

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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