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

NCT ID: NCT05432128

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2025-12-31

Brief Summary

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.

Detailed 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.

Conditions

Lung Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Low-risk group

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.

No interventions assigned to this group

medium-risk group

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

No interventions assigned to this group

High-risk group

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.

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

China-Japan Friendship Hospital

OTHER

Sponsor Role: collaborator

Singlera Genomics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rui Liu, Doctor

Role: PRINCIPAL_INVESTIGATOR

Singlera Genomics Inc.

Locations

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Meng Yang, Bachelor

Role: CONTACT

1943826591@qq.com

18618307980

Sinan Wu

Role: CONTACT

tks0423@hotmail.com

13810293738

Facility Contacts

Meng Yang, Bachelor

Role: primary

1943826591@qq.com

18618307980

Sinan Wu

Role: backup

tks0423@hotmail.com

13810293738

References

Yang M, Yu H, Feng H, Duan J, Wang K, Tong B, Zhang Y, Li W, Wang Y, Liang C, Sun H, Zhong D, Wang B, Chen H, Gong C, He Q, Su Z, Liu R, Zhang P. Enhancing the differential diagnosis of small pulmonary nodules: a comprehensive model integrating plasma methylation, protein biomarkers, and LDCT imaging features. J Transl Med. 2024 Oct 31;22(1):984. doi: 10.1186/s12967-024-05723-5.

Reference Type: DERIVED

PMID: 39482707 (View on PubMed)

Other Identifiers

2019YFC1315803

Identifier Type: -

Identifier Source: org_study_id