Biomarker Discovery in Lung Cancer - Malaysia

University of Malaya

Status: Enrolling

Conditions: Lung Cancer

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06504927

PRO-MAS-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 30+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

400 participants in 2 patient groups

A - High risk cohort

Description:

i. Male or female subjects aged 30 and above. ii. No previous history of any cancers. iii. Able to provide X-ray and/or LDCT results. iv. Have one of the following conditions: 1. COPD 2. Pulmonary nodules measuring less than 11mm, or deemed not for biopsy by attending physician v. Willing to go back for a follow-up X-ray or LDCT scan in the next clinical follow up as per standard of care. vi. 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).

B - Highly suspicious of lung cancer

Description:

i. Male or female subjects aged 30 and above. ii. No previous history of any cancers. iii. Able to provide X-ray and/or LDCT results. iv. Have one of the following conditions: 1. Suspicious nodules measuring more than 11mm. 2. Imaging diagnosis suggestive of lung cancer. v. Willing to enrol for biopsy for confirmation. vi. Willing to provide up to 39mL of blood in month-0 (first visit) and up to 21mL in the next standard of care follow up visit (second visit).