Biomarker Discovery in Lung Cancer - Malaysia

NCT06504927 | Recruiting DMC

• 1 other identifier: PRO-MAS-002
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to

1. 1.Identify biomarkers and signatures to differentiate between high-risk and lung cancer patients.
2. 2.Discover blood-based biomarkers that can be used as an adjunct test to imaging diagnosis to improve patient follow-up.

Conditions

Lung Cancer

Outcome Measures

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.

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

  3 years

Study Arms (2)

A - High risk cohort

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).

B - Highly suspicious of lung cancer

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).

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cohort A Subjects in this cohort are recruited if they have either of the following: pre-existing chronic obstructive pulmonary disease (COPD) or are found to have lung nodules smaller than 11mm, or nodules that are deemed not for biopsy by the attending physician. Cohort B Subjects in this cohort are highly suspicious of having lung cancer. From the results of the X-ray or LDCT imaging, the subject would have nodules larger than 11mm, or show signs of lung cancer.

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Malaya: lead
• MiRXES Pte Ltd: collaborator

Study Sites (1)

University of Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Mau Ern Poh

  University of Malaya

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mau Ern Poh

CONTACT

+60379494422; ernestpoh@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Dr Poh Mau Ern

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 17, 2024
• Study Start: January 16, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)