Diagnostic and Monitoring Significance of ctDNA Methylation Analysis by NGS in Benign and Malignant Pulmonary Nodules

AnchorDx Medical

Status: Active, not recruiting

Conditions: Pulmonary Nodules

Treatments: Diagnostic Test: ctDNA methylation analysis by NGS

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03651986

AnchorDx LC201801

Details and patient eligibility

About

AnchorDx is using circulating tumor DNA (ctDNA) methylation analysis by next-generation sequencing (NGS) to develop a blood-based assay for differentiating benign and malignant pulmonary nodules early. The purpose of this study is to evaluate the diagnostic performance of this assay in patients with pulmonary nodules.

Full description

This is a prospective, multi-center, observational cohort study and seeks to enroll 10,560 participants with pulmonary nodules smaller than 3 cm in diameter from 21 hospitals in China. All participants will be followed up with chest CT or low-dose computed tomography (LDCT) scans for 2-3 years ( baseline, 3 months, 6 months, 12 months, 24 months and 36 months). Their blood samples, CT or LDCT scans data, and clinical data will be collected at each visit and Formalin-fixed paraffin-embedded (FFPE) tissues will be collected when participants who receive pneumonectomy or percutaneous lung biopsy.

Enrollment: 10,560 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 Years and older

• pulmonary nodules diagnosed by chest CT or low-dose computed tomography (LDCT) scans

  • non-calcified pulmonary nodules with the diameter between 5mm to 30mm
  • including solid nodules, mixed ground-glass opacity nodules and pure ground-glass opacity lung modules

• new cases of pulmonary nodules or diagnosed within 60 days prior to enrollment

• agree to finish the Patient Pulmonary History Questionnaire

• agree to be followed up for 2-3 years

• agree to provide a written informed consent

Exclusion criteria

• pregnant or lactating women
• received any pneumonectomy or percutaneous lung biopsy before enrollment
• recipients of blood transfusions within 30 days prior to enrollment
• patients with tumors identified within 2 years prior to enrollment except non-melanoma skin cancer
• fail to understand or provide a written informed consent

Trial design

10,560 participants in 1 patient group

Prospective Cohort

Description:

This is a prospectively enrolling cohort study and a stratified case-cohort design will be employed to select malignant pulmonary nodules cases and benign pulmonary nodules subjects who will be assayed. All participants will be followed up with chest CT or low-dose computed tomography (LDCT) scans for 2-3 years, and take the diagnostic test, ctDNA methylation analysis by NGS, at each visit.

Treatment:

Diagnostic Test: ctDNA methylation analysis by NGS