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| Name | Class |
|---|---|
| MiRXES Pte Ltd | INDUSTRY |
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This study aims to
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
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:
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). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mau Ern Poh | Contact | +60379494422 | ernestpoh@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mau Ern Poh | University of Malaya | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Malaya Medical Centre | Recruiting | Kuala Lumpur | 59100 | Malaysia |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 16, 2024 | Jul 10, 2024 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 16, 2024 | Jul 16, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Blood
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |