Biomarker Discovery in Lung Cancer - Malaysia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Lung Cancer. Basic parameters: from 30 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Malaysia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- To discover and validate RNA and methylated cell-free DNA cancer biomarkers that can discriminate between high-risk and lung cancer patients. [Time frame: 3 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Malaysia · 1 center
- University of Malaya Medical Centre — Kuala Lumpur
Identifiers
NCT: NCT06504927 · PRO-MAS-002