Clinical trial NCT05380999: The Red Blood Cells Based Blood Test for Lung Cancer EARLY Detection
Official title: The Training and Validation Study: Development of a Red Blood Cells Based Blood Test for Early Detection of Lung Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Lung Cancer
Red Blood Cells
Methylation
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
Collaborators: name: Peking Union Medical College Hospital
name: Shanghai Chest Hospital
name: Guangzhou Panyu Central Hospital
name: My-BioMed Technology （Guangzhou） Co., Ltd.
First posted: 2022-05-19
Enrollment: 852
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: 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.
timeFrame: 3 years
measure: 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.
timeFrame: 3 years
measure: 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.
timeFrame: 3 years
measure: 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.
timeFrame: 3 years
Secondary outcomes:
measure: Sensitivity of the RBCs-based methylation assay in the invasion of malignant pulmonary nodules.
timeFrame: 3 years
measure: Specificity of the RBCs-based methylation assay in the invasion of malignant pulmonary nodules.
timeFrame: 3 years
measure: 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.
timeFrame: 3 years
measure: Sensitivity in the model established in this study will compare with that of Mayo Clinic and Veterans Affairs models.
timeFrame: 3 years
measure: Specificity in the model established in this study will compare with that of Mayo Clinic and Veterans Affairs models.
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Tao Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: