Clinical trial NCT05415670: Benign/Malignant Pulmonary Nodule Classification Based on High-throughput Whole-genome Methylation Sequencing(GM-seq)
Official title: Development a Pulmonary Nodules Diagnosis Classification Model for Benign/Malignant of Bronchoscopic Biopsy Specimens Based on High-throughput Whole-genome Methylation Sequencing(GM-seq)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Nodule, Solitary
Whole-genome Methylation Sequencing
Keywords: ctDNA
Pulmonary Nodule, Solitary
Whole-genome Methylation Sequencing(GM-seq)
Machine learning
Lead sponsor: Geneplus-Beijing Co. Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Beijing Hospital
name: Emergency General Hospital
First posted: 2022-06-13
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with pulmonary nodules suspected of early lung cancer

Brief summary: Lung cancer is the first cancer in China in terms of morbidity and mortality. The problem of early diagnosis/treatment has always been concerned. The popularization of chest CT (electronic computed tomography) screening makes it possible to detect lung cancer early. However, the diagnosis still needs pathological evidence. It is an ideal choice to obtain pathological evidence through bronchoscope and other minimally invasive means before surgical resection. However, the positive rate of tracheoscopy is still unsatisfactory, which is related to the difficulty of traditional pathological detection in detecting small specimens obtained by tracheoscopy. Liquid biopsy technology based on methylation detection has been used in early cancer screening, but its advantages have not been fully exploited due to the low content of ctDNA (circulating tumor DNA) in the current detection samples. Therefore, through prospective clinical research, the investigators plan to combine the methylation detection technology based on "Whole genome methylation sequencing(GM-seq)" with tracheoscopy, compare the traditional pathological methods with methylation detection on the bronchoscopic samples of lung nodule subjects suspected of early lung cancer, and take the postoperative pathology as the gold standard for judging benign and malignant, to confirm the feasibility and advantages of the new technology.


Eligibility criteria: Inclusion Criteria:

1. Male or female, 20-75 year-old with pulmonary nodules 1-3cm in diameter confirmed by chest CT;
2. The nodules are single or multiple, suspected to be malignant, and have the indication of surgical resection;
3. Patient accept imaging evaluation without advanced lung tumors and metastases;
4. The location of the nodule in the lung is within the reach of lung biopsy under bronchoscope;
5. provide the collected clinical data needed by the research;
6. Patients have the ability to follow the planned schedule and actively cooperate to return to the hospital for regular clinical visits.

Exclusion criteria:

1. Unwilling to accept the invasive examination and treatment of this study;
2. Contraindication of tracheoscopy;
3. Consider that the pulmonary nodules are metastatic tumors or unresectable advanced lung cancer;
4. Those who cannot tolerate resection of pulmonary nodules;
5. Accompanied by other malignant tumors;
6. In the judgment of the researcher, the patient also suffers from other serious diseases that may affect the accuracy of the test;
7. Those who cannot accept the use of contrast-enhanced magnetic resonance imaging (MRI) or contrast-enhanced computed tomography (CT);
8. Any other illness, social / psychological problems, etc. are judged by the researcher to be unsuitable for participating in this study.

Primary outcomes:
measure: Area under the receiver operating characteristic curve (ROC)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Emergency general hospital
state: Beijing
city: Beijing
country: China
facility: Beijing hospital
state: Beijing
Study officials:
affiliation: Beijing Hospital
name: Wei Zhou, Doctor
role: STUDY_CHAIR
affiliation: Emergency General Hospital
name: Yunzhi Zhou, Doctor
role: STUDY_DIRECTOR
References: