Molecular typing system for early lung cancer diagnosis
Molecular Typing System for Early Screening and Diagnosis of Lung Cancer Combined With Liquid Biopsy Technology
This study is testing a new way to spot lung cancer early by combining blood tests and advanced imaging techniques for people with lung nodules.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Singlera Genomics Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT05432128 on ClinicalTrials.gov |
What this trial studies
This observational study aims to establish a molecular typing system for the early diagnosis of lung cancer by utilizing advanced liquid biopsy techniques to detect ctDNA methylation. It combines AI analysis of low-dose CT images with ctDNA methylation detection to improve the accuracy and efficiency of early lung cancer screening and diagnosis. Patients with pulmonary nodules will undergo both AI detection and blood tests, with follow-ups to assess the sensitivity and specificity of the molecular markers. The ultimate goal is to enhance early detection rates and improve survival outcomes for high-risk populations.
Who should consider this trial
Good fit: Ideal candidates include patients aged 18-75 with pulmonary nodules confirmed by chest CT, measuring between 5-30mm in diameter.
Not a fit: Patients already diagnosed with lung cancer or those with other significant pulmonary conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve early detection and diagnosis of lung cancer, leading to better patient outcomes.
How similar studies have performed: Other studies utilizing similar approaches of combining liquid biopsy and imaging analysis have shown promising results, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with pulmonary nodules confirmed by chest CT are not limited to single nodules; 2. Nodule diameter 5-30mm 3. Nodules include solid, semi-solid and ground glass nodules; 4. Age 18-75, no gender limitation; 5. The newly diagnosed patients did not receive surgery, radiotherapy, chemotherapy, targeted therapy or other tumor-related interventions; 6. Sign informed consent. Exclusion Criteria: 1. Patients with diagnosed lung cancer and extrapulmonary malignant tumor; 2. Pulmonary sarcoidosis, pulmonary vasculitis, pulmonary tuberculosis; 3. Patients with poor compliance are expected to be unable to complete follow-up according to the study protocol; 4. Major trauma requiring blood transfusion occurred within one week before enrollment; 5. Pregnant and lactation patients.
Where this trial is running
Beijing, Beijing
- China-Japan Friendship Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Principal investigator: Rui Liu, Doctor — Singlera Genomics Inc.
- Study coordinator: Meng Yang, Bachelor
- Email: 1943826591@qq.com
- Phone: 18618307980
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.