An observational study in Pulmonary Nodule, Solitary, sponsored by The First Affiliated Hospital of Guangzhou Medical University. Completed at 14 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-02.
Sponsored by The First Affiliated Hospital of Guangzhou Medical University · Observational
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.
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.
188 studies on the registry are indexed under Multiple Pulmonary Nodules; 60 are open to participants now.
This study's enrollment of 1,490 is above the median of 255 across 87 observational studies indexed under Multiple Pulmonary Nodules.
Browse Multiple Pulmonary Nodules studies →The First Affiliated Hospital of Guangzhou Medical University is the lead sponsor of 158 studies on the registry; 65 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Pre-surgery adult patients with single pulmonary nodule found by CT scan.
Exclusion Criteria:
Methylation profiling by high-throughput bisulfite DNA sequencing in blood sample to differentiate benign and malignant pulmonary nodules
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)
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).
Time frame: 1 year
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital of Guangzhou Medical University