Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:44 AM
Study NCT ID:
NCT03605602
Status:
UNKNOWN
Last Update Posted:
2020-02-07
First Post:
2018-07-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Real World Study Based on NGS (TRUMPRWS)
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2700}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-06', 'studyFirstSubmitDate': '2018-07-05', 'studyFirstSubmitQcDate': '2018-07-26', 'lastUpdatePostDateStruct': {'date': '2020-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical relevance between genomic profiling and overall survival', 'timeFrame': '[ Time Frame: From registration onto that step until death, or censored at the date of last contact, assessed up to 3 years]', 'description': 'Kaplan-meier analysis of overall survival based on different genetic alteration'}], 'secondaryOutcomes': [{'measure': 'The characteristics of genomic variation and dynamic changes during different anti-tumor treatment', 'timeFrame': '24 months', 'description': 'Subtypes, incidence and dynamic changes of genomic variants during treatment process.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-Small Cell Carcinoma of Lung, TNM Stage 4']}, 'referencesModule': {'references': [{'pmid': '37488286', 'type': 'DERIVED', 'citation': 'Liu SM, Tu HY, Wei XW, Yan HH, Dong XR, Cui JW, Zhou Z, Xu CR, Zheng MY, Li YS, Wang Z, Bai XY, Li AN, Sun YL, Huang J, Lin JX, Ke EE, Xu BF, Lu C, Du Y, Chen Y, Ma R, Wang BH, Cang SD, Wang BC, Chen HJ, Yang JJ, Li Y, Zhou Q, Wu YL. First-line pyrotinib in advanced HER2-mutant non-small-cell lung cancer: a patient-centric phase 2 trial. Nat Med. 2023 Aug;29(8):2079-2086. doi: 10.1038/s41591-023-02461-x. Epub 2023 Jul 24.'}, {'pmid': '35659479', 'type': 'DERIVED', 'citation': 'Liu SM, Yan HH, Wei XW, Lu C, Dong XR, Du Y, Cui JW, Chen Y, Ma R, Wang BH, Zhou Z, Cang SD, Yang JJ, Tu HY, Zhang XC, Zhong WZ, Zhou Q, Wu YL. Biomarker-Driven Studies With Multi-targets and Multi-drugs by Next-Generation Sequencing for Patients With Non-Small-Cell Lung Cancer: An Open-Label, Multi-center, Phase II Adaptive Umbrella Trial and a Real-World Observational Study (CTONG1702&CTONG1705). Clin Lung Cancer. 2022 Nov;23(7):e395-e399. doi: 10.1016/j.cllc.2022.05.009. Epub 2022 May 11.'}]}, 'descriptionModule': {'briefSummary': 'This is a descriptive observational study, in which data are collected in an epidemiological fashion. This study does not intend to alter or intervene the current medical practice of the recruited patients. Data will be collected in prospective manner.', 'detailedDescription': 'This is a descriptive observational study, in which data are collected in an epidemiological fashion. This study does not intend to alter or intervene the current medical practice of the recruited patients. Data will be collected in prospective manner.\n\nThe eligible patients will be recruited after NGS analysis for tumor tissue and the inform-consent is obtained. The study required information will be collected (every 3 months).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Histologically or cytologically confirmed NSCLC', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients must be ≥20 years of age.\n2. Provision of fully informed consent prior to any study specific procedures.\n3. Histologically or cytologically confirmed, unresectable stage IIIB or stage IV NSCLC.\n4. Genetic variants of tumor tissue detected by NGS.\n\nExclusion Criteria:\n\nNone.'}, 'identificationModule': {'nctId': 'NCT03605602', 'acronym': 'TRUMPRWS', 'briefTitle': 'A Real World Study Based on NGS (TRUMPRWS)', 'organization': {'class': 'OTHER', 'fullName': 'Guangdong Association of Clinical Trials'}, 'officialTitle': 'TRUMPRWS: A Non-interventional Study on Genetic Variants and Its Clinical Relevance in Chinese Patients With Advanced NSCLC (TRUMPRWS)', 'orgStudyIdInfo': {'id': 'CTONG1705'}}, 'armsInterventionsModule': {'interventions': [{'name': 'No treatment is included in this protocol.', 'type': 'OTHER', 'description': 'No drug intervention or tissue sampling will be included in this study.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yi-Long Wu, Professor', 'role': 'CONTACT', 'email': 'syylwu@live.cn', 'phone': '+862083827812'}, {'name': 'Xiao-Yan Bai, Dr.', 'role': 'CONTACT', 'email': '799836599@qq.com', 'phone': '+86 15347435499'}], 'facility': "Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, School of Medicine, South China University of Technology", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Yi-Long Wu, Professor', 'role': 'CONTACT', 'email': 'syylwu@live.cn', 'phone': '+86 20 83827812'}, {'name': 'Xiao-Yan Bai, Dr.', 'role': 'CONTACT', 'email': '799836599@qq.com', 'phone': '+8615347435499'}], 'overallOfficials': [{'name': 'Yi-Long Wu, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Guangdong Association of Clinical Trials (GACT)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangdong Association of Clinical Trials', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}