To Establish a Molecular Typing System for Early Diagnosis of Lung Cancer

Singlera Genomics

Status: Enrolling

Conditions: Lung Cancer

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05432128

2019YFC1315803

Details and patient eligibility

About

This topic to take large multicenter study real world, the advanced liquid biopsy will ctDNA methylation detection technique is applied to pulmonary nodules differential diagnosis and early lung cancer screening, validation of early lung cancer screening and diagnosis of molecular classification system model, the feasibility of the development of early lung cancer screening and diagnosis of molecular classification system, improve its early screening early detection accuracy and efficiency, Improve the survival status of lung cancer high-risk population. At the same time, this project combined AI analysis technology of LDCT image results with ctDNA methylation detection, so as to overcome false negatives caused by the deficiency of ctDNA methylation detection technology in sensitivity, specificity, stability and flux, and correct false positive results that may be caused by AI analysis technology of LDCT image results. The combination of the two can avoid missed diagnosis and over - examination and over - treatment.

Full description

1. All patients underwent low-dose CT pulmonary nodule AI detection and peripheral blood ctDNA methylation detection at baseline
2. Follow-up plan: Low-risk and medium-risk nodules and some high-risk nodules (5-10mm) were followed up. 10ml peripheral blood was collected from each follow-up and stored for testing until the end of the study. The high-risk nodules over 10mm were evaluated by the expert group and the patients were informed by biopsy or surgical resection. Histopathological diagnosis was made and compared with ctDNA methylation results to analyze the sensitivity and specificity of ctDNA methylation markers of lung cancer.
3. Endpoint: Tissue samples were pathologically diagnosed as benign or malignant.

Enrollment: 600 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

600 participants in 3 patient groups

Low-risk group

Description:

Combined with AI calculation of malignant probability and ctDNA methylation results, patients were divided into three groups. The high probability of malignancy calculated by AI was defined as positive, and vice versa. The methylation markers detected in specific peripheral blood of lung cancer were defined as positive, and vice versa. Negative for both items was considered as low risk group. Follow-up was conducted according to The Chinese Expert Consensus on the Diagnosis and Treatment of Pulmonary Nodules (2018 edition). 10ml peripheral blood was collected from each follow-up and stored for testing until the end of the study.

medium-risk group

Description:

As above, one positive patient was considered to be in the medium-risk group and was reexamined every 6 months, with a total of 3 reexaminations expected

High-risk group

Description:

Same as above, both positive are considered high-risk group.Part of high-risk nodules (5-10mm) will be reviewed every 3 months for the above two examinations, which is expected to be reviewed 6 times in total. Biopsy or surgical resection of high-risk nodules over 10mm will be performed after evaluation by the expert group and the patient's knowledge, and histopathological diagnosis will be made and compared with ctDNA methylation results. To analyze the sensitivity and specificity of ctDNA methylation markers in lung cancer.