Developing Novel Circulating Epigenetic Biomarkers for Early Detection of Lung Cancer

NCT04814407 | Recruiting

• 1 other identifier: 202012096RIPC
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim to identify novel circulating methylated biomarkers for early lung cancer detection as well as to develop new technologies that are clinically applicable with high sensitivity and specificity.

Conditions

Lung Cancer

Keywords

Lung cancer; Cell-free DNA; DNA methylation; T cell methylome; cell-free tumor DNA (ctDNA)

Outcome Measures

Primary Outcomes (3)

• Identification of circulating tumor and immune methylated signature

  Genome-wide methylation profile of lung cancer patients and control subjects will be measured both in circulating T cells and cell-free DNA collected from peripheral blood by using Infinium MethylationEPIC BeadChip platform.

  1 year

• Technology development

  The investigators will develop enriched methylation-specific droplet digital PCR (EMS-ddPCR) with increased sensitivity and decreased input DNA requirement. The investigators will develop single-cell, locus-specific DNA methylation detection system for flow cytometry (scLSM-FACS) to enable cell-type specific methylation detection.

  1 year

• Technology validation

  The investigators will validate the identified circulating methylated signature in patients with indeterminate pulmonary nodules.

  1 year

Study Arms (3)

Lung cancer patients

Patients age over 20, with suspected or confirmed diagnosis of lung cancer.

Diagnostic Test: Blood-derived DNA methylation detection

Indeterminate subjects

Subjects who had indeterminate sub-centimeter pulmonary nodules or ground glass opacities discovered by computed tomography.

Diagnostic Test: Blood-derived DNA methylation detection

Control subjects

Non-cancer patients including healthy volunteers, chronic inflammatory airway diseases such as chronic obstructive airway disease, asthma, and bronchiectasis, etc.

Diagnostic Test: Blood-derived DNA methylation detection

Interventions

Blood-derived DNA methylation detection DIAGNOSTIC_TEST

Up to 20 ml of blood will be collected from each subject, and the blood specimen will be processed to isolate plasma cell-free DNA and immune-derived cells (circulating T cells). Circulating methylated tumor/immune signature will then be identified.

Control subjects; Indeterminate subjects; Lung cancer patients

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Study subjects: Patients with suspected or confirmed diagnosis of lung cancer. 2. Indeterminate subjects: Subjects who had indeterminate sub-centimeter pulmonary nodules or ground glass opacities discovered by computed tomography. 3. Control subjects: Non-cancer subjects including healthy volunteers, chronic inflammatory airway diseases such as chronic obstructive airway disease, asthma, and bronchiectasis, etc.

You may qualify if:

• Subjects suspected or confirmed diagnosis of lung cancer.
• Subjects who had indeterminate sub-centimeter pulmonary nodules or ground glass opacities discovered by computed tomography.
• Non-cancer subjects: including healthy volunteers and chronic inflammatory airway diseases such as chronic obstructive airway disease, asthma, and bronchiectasis, etc.
• Subjects age over 20.

You may not qualify if:

• Pregnancy.
• Subjects with HIV infection.
• Unable to or unwilling to give informed consent.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100225, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

plasma, PBMC

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Hsing-Chen Tsai, M.D., Ph.D

  Graduate institute of Toxicology, NTUCM; Department of Internal Medicine, NTUH

  STUDY CHAIR

Central Study Contacts

Hsing-Chen Tsai, M.D., Ph.D

CONTACT

+886-2-23123456; htsai@ntu.edu.tw

Study Design

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

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: March 24, 2021
• Study Start: March 1, 2021
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 18, 2024

Record last verified: 2024-06

Locations

TW (1)