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

NCT ID: NCT05380999

Last Updated: 2022-05-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 852 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-31
• Study Completion Date: 2026-03-31

Brief 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

Study Design

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

Study Groups

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

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

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

Intervention Type: DIAGNOSTIC_TEST

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).

Interventions

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).

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

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

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: collaborator

Shanghai Chest Hospital

OTHER

Sponsor Role: collaborator

Guangzhou Panyu Central Hospital

OTHER

Sponsor Role: collaborator

My-BioMed Technology （Guangzhou） Co., Ltd.

UNKNOWN

Sponsor Role: collaborator

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tao Wang, MD

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Central Contacts

Zichen Jiao, MD

Role: CONTACT

zichenjiao@outlook.com

15895905095

Tao Wang, MD

Role: CONTACT

wangtao_pumc@live.cn

13770794040

Other Identifiers

GL2022-LC001

Identifier Type: -

Identifier Source: org_study_id