Biomarker Discovery in Lung Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-16

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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A - High risk cohort

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).

No interventions assigned to this group

B - Highly suspicious of lung cancer

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).

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes