Biomarker Discovery in Lung Cancer - Malaysia

Last updated: July 16, 2024
Sponsor: University of Malaya
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Cancer

Non-small Cell Lung Cancer

Cancer

Treatment

N/A

Clinical Study ID

NCT06504927
PRO-MAS-002
  • Ages > 30
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 forbiopsy by attending physician

  • Willing to go back for a follow-up X-ray or LDCT scan in the next clinical follow upas per standard of care.

  • Willing to provide up to 30mL of blood in month-0 (first visit) and up to 21mL inthe next standard of care follow up visit (second visit).

Exclusion

Exclusion Criteria:

  • Subject has received chemotherapy or radiotherapy for cancer treatment, and anyother cancer-related treatment.

  • Subject is pregnant or lactating (self-declaration).

  • Subject is unwilling or unable to provide signed informed consent

Study Design

Total Participants: 400
Study Start date:
January 16, 2024
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • University of Malaya Medical Centre

    Kuala Lumpur, 59100
    Malaysia

    Active - Recruiting

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