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

NCT05380999 | Not Yet Recruiting

• 1 other identifier: GL2022-LC001
• Study Type: observational
• Target: 852
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lung Cancer; Red Blood Cells; Methylation

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (5)

• Sensitivity of the RBCs-based methylation assay in the invasion of malignant pulmonary nodules.

  3 years

• Specificity of the RBCs-based methylation assay in the invasion of malignant pulmonary nodules.

  3 years

• 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

• Sensitivity in the model established in this study will compare with that of Mayo Clinic and Veterans Affairs models.

  3 years

• Specificity in the model established in this study will compare with that of Mayo Clinic and Veterans Affairs models.

  3 years

Study Arms (1)

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.

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

Interventions

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

1. The pulmonary nodule is ≤30mm as assessed by imaging; nodules were suspected to be malignant, 2. Plan to use biopsy or surgery for diagnosis or treatment within 60 days.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood specimen

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Tao Wang, MD

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zichen Jiao, MD

CONTACT

15895905095; zichenjiao@outlook.com

Tao Wang, MD

CONTACT

13770794040; wangtao_pumc@live.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2022
• First Posted: May 19, 2022
• Study Start: May 1, 2022
• Primary Completion: March 29, 2025
• Study Completion: March 1, 2026
• Last Updated: May 19, 2022

Record last verified: 2022-05