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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05380999
• Other study ID #: GL2022-LC001
• Status: Not yet recruiting
• Start date: May 2022
• Est. completion date: March 2026

Study information

• Verified date: May 2022
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: Zichen Jiao, MD
• Phone: 15895905095
• Email: zichenjiao[@]outlook.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 852
• Est. completion date: March 2026
• Est. primary completion date: March 29, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Methylation
• Red Blood Cells

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Guangzhou Panyu Central Hospital, My-BioMed Technology (Guangzhou) Co., Ltd., Peking Union Medical College Hospital, Shanghai Chest Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of the RBCs-based blood test for differentiating benign and malignant pulmonary nodules diameter less than 3 cm using DNA methylation analysis by NGS.		3 years
Primary	Specificity of the RBCs-based blood test for differentiating benign and malignant pulmonary nodules diameter less than 3 cm using DNA methylation analysis by NGS.		3 years
Primary	Positive predictive value (PPV) of the RBCs-based blood test for differentiating benign and malignant pulmonary nodules diameter less than 3 cm using DNA methylation analysis by NGS.		3 years
Primary	Negative predictive value (NPV) of the RBCs-based blood test for differentiating benign and malignant pulmonary nodules diameter less than 3 cm using DNA methylation analysis by NGS.		3 years
Secondary	Sensitivity of the RBCs-based methylation assay in the invasion of malignant pulmonary nodules.		3 years
Secondary	Specificity of the RBCs-based methylation assay in the invasion of malignant pulmonary nodules.		3 years
Secondary	Area under curve (AUC) of receiver operating characteristic curve (ROC) in the model established in this study will compare with that of Mayo Clinic and Veterans Affairs models.		3 years
Secondary	Sensitivity in the model established in this study will compare with that of Mayo Clinic and Veterans Affairs models.		3 years
Secondary	Specificity in the model established in this study will compare with that of Mayo Clinic and Veterans Affairs models.		3 years