Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT03519958
Status:
WITHDRAWN
Last Update Posted:
2018-11-16
First Post:
2018-02-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Epidermal Growth Factor Receptor (EGFR) T790M Mutation Testing Practices in Hong Kong
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Plasma for T7909M ctDNA testing Urine for T7909M ctDNA testing Tissue (optional)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': "The study direction does not longer aligns the sponsor's strategy", 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-09-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2020-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-15', 'studyFirstSubmitDate': '2018-02-19', 'studyFirstSubmitQcDate': '2018-04-30', 'lastUpdatePostDateStruct': {'date': '2018-11-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Concordance', 'timeFrame': '3 years', 'description': 'To analyze the concordance of T790M mutation status as determined by urine, plasma, and tissue/cytology T790M testing'}], 'primaryOutcomes': [{'measure': 'EGFR T790M mutation prevalance', 'timeFrame': '3 years', 'description': 'Based on the plasma-tissue testing algorithm in NSCLC patients who progressed on previous EGFR TKI therapy'}], 'secondaryOutcomes': [{'measure': 'Proportion of Valid Tissue T790M Testing Result', 'timeFrame': '3 years', 'description': 'Proportion of study subjects who have a valid tissue/cytology T790M testing result after receiving a negative plasma test result for the T790M mutation'}, {'measure': 'T790M Plasma Outcome', 'timeFrame': '3 years', 'description': 'Proportions of study subjects who are T790M plasma-negative'}, {'measure': 'False Negative Proportation', 'timeFrame': '3 years', 'description': 'Proportion of study subjects who are T790M plasma-negative but T790M tissue/cytology-positive'}, {'measure': 'Reasons for not performing re-biopsy', 'timeFrame': '3 years', 'description': 'reasons given for not performing re-biopsy and tissue/cytology testing after obtaining a negative plasma test result'}, {'measure': 'Demographics', 'timeFrame': 'Baseline', 'description': 'Demographics of T790M-positive subjects and T790M-negative subjects'}, {'measure': 'Disease Characteristics', 'timeFrame': '3 years', 'description': 'Disease characteristics of T790M-positive subjects and T790M-negative subjects'}, {'measure': 'Number of particapants with complications assoicated with re-biopsy', 'timeFrame': '3 years', 'description': 'Number of particapants with complications assoicated with tissue/cytology re-biopsy'}, {'measure': 'Clinical Outcomes in T790M plasma-positive subejects', 'timeFrame': '3 years', 'description': 'Clinical outcomes after osimertinib treatment between study subjects who are T790M plasma-positive'}, {'measure': 'Clinical Outcomes in urine-positive', 'timeFrame': '3 years', 'description': 'Clinical outcomes after osimertinib treatment between study subjects who are urine-positive'}, {'measure': 'Clinical Outcomes in tissue/cytology-positive', 'timeFrame': '3 years', 'description': 'Clinical outcomes after osimertinib treatment between study subjects who are tissue/cytology-positive'}]}, 'conditionsModule': {'conditions': ['Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'To describe the T790M mutation status of patients with locally advanced/metastatic NSCLC who progressed on previous EGFR TKI treatment in a real-world setting.', 'detailedDescription': 'This is a multi-center, observational study of patients with locally advanced/metastatic NSCLC who progressed on previous EGFR TKI treatment. Eligible patients will be recruited from participating sites in Hong Kong over a 12 months enrolment period.\n\nPlasma and urine samples will be collected from enrolled patients. Plasma circulating tumor DNA (ctDNA) and urine ctDNA will be analyzed by droplet digital PCR (ddPCR) for detection of T790M mutation and EGFR sensitizing mutations. Patients who are T790M plasma-negative, regardless of the urine testing results, will be recommended to undergo re-biopsy (defined as tissue sampling or cytology sampling), tissue/cytology T790M testing, and to provide a second plasma sample for a second plasma T790M test (tested by ddPCR).\n\nEnrolled patients who subsequently receive osimertinib treatment will be followed up as per routine practice at the investigational site. Patient data will be collected for 12 months or until death or loss to follow-up, whichever occurs earlier, from the first prescription of osimertinib. All clinical decisions will be at the discretion of the treating physician.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will enrol locally advanced or metastatic NSCLC patients with confirmed EGFR sensitizing mutation, who progressed after EGFR TKI treatment (i.e.,gefitinib, erlotinib, afatinib), and are suggested to undergo T790M mutation testing by their treating physicians in participating sites in Hong Kong', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Provision of written informed consent\n* Locally advanced (stage IIIB) or metastatic (stage IV) NSCLC, not amenable to curative surgery or radiotherapy\n* Confirmed EGFR sensitizing mutation (exon 19 deletion or exon 21 L858R ) in medical record\n* Progressed on previous EGFR TKI treatment, based on physician judgement, with or without additional lines of treatment\n* Suggested to undergo T790M mutation testing by treating physician, based on physician judgement\n\nExclusion Criteria\n\n* Had been treated with osimertinib or any other 3rd generation T790M inhibitors\n* Enrollment in studies that prohibit participation in this observational study'}, 'identificationModule': {'nctId': 'NCT03519958', 'briefTitle': 'Epidermal Growth Factor Receptor (EGFR) T790M Mutation Testing Practices in Hong Kong', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'An Observational, Multi-centre Study on EGFR T790M Mutation Testing Practices and Outcomes Conducted Among Locally Advanced/Metastatic NSCLC Patients Who Progressed on Previous EGFR Tyrosine-kinase Inhibitor (TKI) Therapy in Hong Kong', 'orgStudyIdInfo': {'id': 'D5160R00019'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'EGFR NSCLC Progressed on EGFR TKI', 'description': 'Patients with EGFR NSCLC who have progressed following EGFR TKI therapy will undergo plasma-tissue testing', 'interventionNames': ['Diagnostic Test: Plasma-tissue testing']}], 'interventions': [{'name': 'Plasma-tissue testing', 'type': 'DIAGNOSTIC_TEST', 'description': 'EGFR T790M mutation plasma-tissue testing in NSCLC patients who progressed on previous EGFR TKI', 'armGroupLabels': ['EGFR NSCLC Progressed on EGFR TKI']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'James Ho, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Queen Mary Hospital, Hong Kong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}