Ignite Creation Date:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-04-01 @ 10:07 PM
Study NCT ID:
NCT06504927
Status:
RECRUITING
Last Update Posted:
2024-07-18
First Post:
2024-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarker Discovery in Lung Cancer - Malaysia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-01-16', 'size': 392487, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-07-10T11:44', 'hasProtocol': True}, {'date': '2024-01-16', 'size': 103489, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-07-16T12:23', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-16', 'studyFirstSubmitDate': '2024-07-10', 'studyFirstSubmitQcDate': '2024-07-10', 'lastUpdatePostDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To discover and validate RNA and methylated cell-free DNA cancer biomarkers that can discriminate between high-risk and lung cancer patients.', 'timeFrame': '3 years', 'description': 'To discover and validate RNA and methylated cell-free DNA cancer biomarkers that can discriminate between high-risk and lung cancer patients.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This study aims to\n\n1. Identify biomarkers and signatures to differentiate between high-risk and lung cancer patients.\n2. Discover blood-based biomarkers that can be used as an adjunct test to imaging diagnosis to improve patient follow-up.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.\n\nCohort 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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subjects aged 30 and above.\n* No previous history of any cancers.\n* Able to provide X-ray and/or LDCT results.\n* Have either COPD or pulmonary nodules measuring less than 11mm, or deemed not for biopsy by attending physician\n* Willing to go back for a follow-up X-ray or LDCT scan in the next clinical follow up as per standard of care.\n* 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).\n\nExclusion Criteria:\n\n* Subject has received chemotherapy or radiotherapy for cancer treatment, and any other cancer-related treatment.\n* Subject is pregnant or lactating (self-declaration).\n* Subject is unwilling or unable to provide signed informed consent'}, 'identificationModule': {'nctId': 'NCT06504927', 'briefTitle': 'Biomarker Discovery in Lung Cancer - Malaysia', 'organization': {'class': 'OTHER', 'fullName': 'University of Malaya'}, 'officialTitle': 'Biomarker Discovery in Lung Cancer - Malaysia', 'orgStudyIdInfo': {'id': 'PRO-MAS-002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'A - High risk cohort', 'description': '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:\n\n1. COPD\n2. Pulmonary nodules measuring less than 11mm, or deemed not for biopsy by attending physician\n\nv. Willing to go back for a follow-up X-ray or LDCT scan in the next clinical follow up as per standard of care.\n\nvi. 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).'}, {'label': 'B - Highly suspicious of lung cancer', 'description': '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:\n\n1. Suspicious nodules measuring more than 11mm.\n2. Imaging diagnosis suggestive of lung cancer.\n\nv. 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).'}]}, 'contactsLocationsModule': {'locations': [{'zip': '59100', 'city': 'Kuala Lumpur', 'status': 'RECRUITING', 'country': 'Malaysia', 'contacts': [{'name': 'Mau Ern Poh, MBBS', 'role': 'CONTACT', 'email': 'ernestpoh@gmail.com'}], 'facility': 'University of Malaya Medical Centre', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}], 'centralContacts': [{'name': 'Mau Ern Poh', 'role': 'CONTACT', 'email': 'ernestpoh@gmail.com', 'phone': '+60379494422'}], 'overallOfficials': [{'name': 'Mau Ern Poh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Malaya'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Malaya', 'class': 'OTHER'}, 'collaborators': [{'name': 'MiRXES Pte Ltd', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor Dr Poh Mau Ern', 'investigatorFullName': 'Poh Mau Ern', 'investigatorAffiliation': 'University of Malaya'}}}}