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临床试验/NCT06504927
NCT06504927招募中不适用

Biomarker Discovery in Lung Cancer - Malaysia

University of Malaya1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2024年1月16日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
400
试验地点
1
主要终点
To discover and validate RNA and methylated cell-free DNA cancer biomarkers that can discriminate between high-risk and lung cancer patients.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
30 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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

结局指标

主要结局

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

时间窗: 3 years

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Poh Mau Ern

Associate Professor Dr Poh Mau Ern

University of Malaya

研究点 (1)

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