An observational study in Lung Cancer, sponsored by Singlera Genomics Inc.. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-04-17.
Sponsored by Singlera Genomics Inc. · Observational
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.
7,334 studies on the registry are indexed under Lung Neoplasms; 1,554 are open to participants now.
This study's planned enrollment of 600 is above the median of 190 across 1,547 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Singlera Genomics Inc. is the lead sponsor of 14 studies on the registry; 8 are open to participants now.
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600 patients who were newly diagnosed with pulmonary nodules confirmed by chest CT
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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.
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
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.
To develop a molecular typing system for early screening and diagnosis of lung cancer
The feasibility of the molecular typing system model for early screening and diagnosis of lung cancer was verified through clinical studies, which significantly improved the accuracy and efficiency of early screening and early diagnosis, and improved the survival status of high-risk population of lung cancer.
Time frame: assessed up to 36 months
AI technology was combined with ctDNA methylation detection technology
In addition to overcoming false negatives caused by deficiencies in sensitivity, specificity, stability and flux of ctDNA methylation detection technology, and correcting false positive results that may be caused by AI, the combination of the two can avoid missed diagnosis, over-examination and over-treatment.
Time frame: assessed up to 36 months
Plan to share: No
This study is status unknown, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Singlera Genomics Inc.