Clinical trial · Observational
Biomarker Discovery in Lung Cancer - Malaysia
NCT06504927CI-TRIAL-00078935recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- 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).
- label
- 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).
Primary outcomes (1)
- measure
- To discover and validate RNA and methylated cell-free DNA cancer biomarkers that can discriminate between high-risk and lung cancer patients.
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 30 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.