Biomarker Discovery in Lung Cancer - Malaysia

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06504927

Enrollment

400

Registered

2024-07-17

Start date

2024-01-16

Completion date

2026-12-31

Last updated

2024-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Malaysia

Contacts

Primary ContactMau Ern Poh

ernestpoh@gmail.com+60379494422

Outcome results