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Recruiting

NCT Number: NCT06504927

Biomarker Discovery in Lung Cancer - Malaysia

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.

Recruiting

Interested in participating?

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Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

Location status: Recruiting

Location contact

Mau Ern Poh, MBBS

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

    To discover and validate RNA and methylated cell-free DNA cancer biomarkers that can discriminate between high-risk and lung cancer patients.

Study contacts

Contact information is provided by the study sponsor or research team.

Mau Ern Poh

CONTACT

[email protected]

+60379494422

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Collaborators

  • MiRXES Pte Ltd

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 17, 2024
Registry last updated
Jul 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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