NCT05380999

The Red Blood Cells Based Blood Test for Lung Cancer EARLY Detection

The Training and Validation Study: Development of a Red Blood Cells Based Blood Test for Early Detection of Lung Cancer

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 852 (estimated)
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study plan to enroll 852 patients with pulmonary nodules smaller than 3 cm in diameter, whose DNA and RNA will be extracted from mature red blood cells isolated from peripheral blood. The DNA 5-methylcytosine(5-mC) and RNA 2'-O-methylation information will be acquired by NGS and Nm Judge Universally sequencing (NJU-Seq), which will be used to establish models to distinguish patients with benign and malignant nodule in the training group and further evaluated in the validation group. The pathological results will be acquired after surgery or biopsy as standard in the study.

Detailed description

This is a prospective, multi-center, observational, cohort study and seeks to enroll 852 participants with pulmonary nodules smaller than 3 cm in diameter from 4 hospitals in China. Each participant pulmonary nodule is ≤30mm as assessed by CT scanning, nodule is suspected to be malignant, and plan to use biopsy or surgery for diagnosis or treatment within 60 days.Their blood samples, CT scan data, and clinical data will be collected at each visit and tissues will be collected when participants who receive pneumonectomy or percutaneous lung biopsy. Each subject will analysis DNA and RNA methylation in nucleic acids extracted from mature red blood cells isolated from peripheral blood by next-generation sequencing (NGS) . A proprietary algorithm will be used to identify the modification sites and pattern for differentiating the benign and malignant pulmonary nodules. Sensitivity and specificity of the different methylation panels will be to evaluated.

Conditions

• Lung Cancer
• Red Blood Cells
• Methylation

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Methylation tests of nucleic acids extracted from mature red blood cells (RBCs)	Up to 15 ml of peripheral blood will be collected from each subject, and the blood specimen will be processed to isolate mature red blood cells and extract the DNA and RNA from RBCs. DNA and RNA methylation will be tested by next-generation sequencing (NGS).

Timeline

• Start date: 2022-05-01
• Primary completion: 2025-03-29
• Completion: 2026-03-01
• First posted: 2022-05-19
• Last updated: 2022-05-19