Biomarker Discovery in Lung Cancer - Malaysia

Recruiting

• Conditions: Lung Cancer

• Registration Number: NCT06504927
• Lead Sponsor: University of Malaya

Brief Summary

This study aims to

1. Identify biomarkers and signatures to differentiate between high-risk and lung cancer patients.

2. Discover blood-based biomarkers that can be used as an adjunct test to imaging diagnosis to improve patient follow-up.

Detailed Description

With existing evidence showing the utility of using liquid biopsy for early cancer detection, the investigators hypothesized that cell-free DNA and/or RNA expression changes during disease progression, and biomarker signature can be derived from the changes in expression levels. The investigators aim to discover and validate RNA and methylated cell-free DNA cancer biomarkers that can discriminate between high-risk and lung cancer patients.

Study Timeline

• Study Start: 2024-01-16
• Status Verified: 2024-07
• Study First Submitted: 2024-07-10
• Study First Submitted QC: 2024-07-10
• Last Update Submitted: 2024-07-16
• Study First Posted: 2024-07-17
• Last Update Posted: 2024-07-18
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Male or female subjects aged 30 and above.
• No previous history of any cancers.
• Able to provide X-ray and/or LDCT results.
• Have either COPD or pulmonary nodules measuring less than 11mm, or deemed not for biopsy by attending physician
• Willing to go back for a follow-up X-ray or LDCT scan in the next clinical follow up as per standard of care.
• Willing to provide up to 30mL of blood in month-0 (first visit) and up to 21mL in the next standard of care follow up visit (second visit).

Exclusion Criteria

• Subject has received chemotherapy or radiotherapy for cancer treatment, and any other cancer-related treatment.
• Subject is pregnant or lactating (self-declaration).
• Subject is unwilling or unable to provide signed informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To discover and validate RNA and methylated cell-free DNA cancer biomarkers that can discriminate between high-risk and lung cancer patients.	3 years	To discover and validate RNA and methylated cell-free DNA cancer biomarkers that can discriminate between high-risk and lung cancer patients.

Trial Locations

Locations (1)

University of Malaya Medical Centre; 🇲🇾 Kuala Lumpur, Malaysia