Circulating Tumor DNA Methylation Test to Differentiate Benign and Malignant Pulmonary Nodules

Multi-centers Validation of a Circulating Tumor DNA Assay to Differentiate Benign and Malignant Pulmonary Nodules Via Targeted High-throughput DNA Methylation Sequencing

Current state-of-the-art lung cancer early screening utilizes low-dose CT scan to identify lung nodules smaller than 3 cm in diameter. However, it's still a clinical challenge to differentiate between malignant and benign nodules.

In previous studies, the investigators had taken the approach of methylation profiling by high throughput bisulfite DNA sequencing in tissue samples to identify specific methylation signatures. The investigators had learned methylation patterns that differentiate malignant vs. benign lesions from tissue samples by in-depth data mining, and then used pattern matching to classify plasma samples.

In this study, the investigators are going to validate the efficacy of ctDNA methylation test for diagnosing early lung cancer by comparing results of the pre-surgery ctDNA methylation test with the post-surgery pathology.

Study Overview

Detailed Description

This is a prospective, multi-center, observational cohort study and seeks to enroll 1230 participants with pulmonary nodules 5-30mm in diameter.

The assay analyzes the ctDNA methylation profiles of lung cancer-specific biomarkers non-invasively using whole blood specimens collected before invasive surgery.

The performance characteristics(sensitivity and specificity) of the pre-surgery ctDNA methylation test for detection of early lung cancer is evaluated in comparison to post-surgery pathology.

Study Type

Observational

Enrollment (Actual)

1490

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Beijing, China
        • Department of Thoracic Surgery, Beijing Cancer Hospital
      • Beijing, China
        • Department of Thoracic Surgery, Xuanwu Hospital, Capital Medical University
      • Changsha, China
        • Department of Thoracic Surgery, The Second Xiangya Hospital of Central South University
      • Changsha, China
        • Department of Thoracic Surgery, Xiangya Hospital, Central South University
      • Chengdu, China
        • Department of Thoracic Surgery, West China Hospital of Sichuan University
      • Guangzhou, China
        • Department of Thoracic Surgery, Nanfang Hospital of Southern Medical University
      • Guangzhou, China
        • Department of Thoracic Surgery, The First Affiliated Hospital of Guangzhou Medical University
      • Guangzhou, China
        • Department of Thoracic Surgery, The First Affiliated Hospital of Sun Yat-sen University
      • Haerbin, China
        • Department of Thoracic Surgery, The Forth Affiliated Hospital of Harbin Medical University
      • Hefei, China
        • Department of Thoracic Surgery, Anhui Chest Hospital
      • Hengyang, China
        • Department of Thoracic Surgery, The Second Hospital,University of South China
      • Jinan, China
        • Department of Thoracic Surgery, Qilu Hospital of Shandong University
      • Nanjing, China
        • Department of Thoracic Surgery, Jiangsu Province Hospital
      • Shenzhen, China
        • Department of Thoracic Surgery, Shenzhen People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Pre-surgery adult patients with single pulmonary nodule found by CT scan.

Description

Inclusion Criteria:

  • 18 years old or above
  • single pulmonary nodule found by CT scan.
  • the diameter of the pulmonary nodule is between 5mm to 30mm.
  • plan to accept pneumonectomy due to the pulmonary nodule.
  • without any sign of lymphatic or distant metastasis.
  • agree to sign informed consent.

Exclusion Criteria:

  • pregnant or lactating women.
  • the diameter of the pulmonary nodule is more than 30mm
  • there are 2 or more pulmonary nodules in one single patient.
  • any sign of lymphatic or distant metastasis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The diagnostic performance of the blood-based assay for differentiating benign and malignant pulmonary nodules early using circulating tumor DNA (ctDNA) methylation analysis by next-generation sequencing (NGS)
Time Frame: 1 year
The efficacy of the blood-based ctDNA methylation assay comparing with pathologic diagnosis, the gold standard, including sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV).
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2017

Primary Completion (Actual)

February 28, 2019

Study Completion (Actual)

May 31, 2019

Study Registration Dates

First Submitted

June 7, 2017

First Submitted That Met QC Criteria

June 7, 2017

First Posted (Actual)

June 8, 2017

Study Record Updates

Last Update Posted (Actual)

April 2, 2020

Last Update Submitted That Met QC Criteria

March 31, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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