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

Nanjing University

Status: Not yet enrolling

Conditions: Red Blood Cells; Lung Cancer; Methylation

Treatments: Diagnostic Test: Methylation tests of nucleic acids extracted from mature red blood cells (RBCs)

Study type: Observational

Funder types: Other

Identifiers

NCT05380999

GL2022-LC001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 852 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Pulmonary nodule is ≤3cm;
2. Subjects suspected of lung cancer;
3. Diagnosis or treatment by biopsy or surgery within 60 days;
4. Signed informed consent.

Exclusion criteria

1. History of malignant tumors;
2. Received anti-tumor therapy;
3. Can't collect the histopathological results or the pathological results are metastatic cancer;
4. Can't obtain detection information of red blood cells;
5. Pregnancy or lactating female；
6. Other situations not suitable for the study.

Trial design

852 participants in 1 patient group

Patients with pulmonary nodules (diameter ≤3cm) plan to diagnosis benign and malignant

Description:

Patients with pulmonary nodules (diameter ≤3cm) plan to use biopsy or surgery or treatment to diagnosis benign and malignant.

Treatment:

Diagnostic Test: Methylation tests of nucleic acids extracted from mature red blood cells (RBCs)