Ignite Creation Date:
2025-12-24 @ 10:16 PM
Ignite Modification Date:
2025-12-25 @ 7:50 PM
Study NCT ID:
NCT04692935
Status:
UNKNOWN
Last Update Posted:
2021-01-05
First Post:
2020-12-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparative Genomic Profiling of Lung Adenocarcinoma in Asians and Caucasians: A Propensity Matched Analysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077192', 'term': 'Adenocarcinoma of Lung'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-03', 'studyFirstSubmitDate': '2020-12-25', 'studyFirstSubmitQcDate': '2020-12-31', 'lastUpdatePostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oncoprint of somatic mutations', 'timeFrame': 'July 2021', 'description': 'Association between genomic features and race'}, {'measure': 'Copy number variations (CNVs)', 'timeFrame': 'July 2021', 'description': 'CNVs analysis by race'}, {'measure': 'Mutational signatures', 'timeFrame': 'August 2021', 'description': 'Analysis of mutational signatures by race'}, {'measure': 'Oncogenic pathways', 'timeFrame': 'September 2021', 'description': 'Analysis of oncogenic pathways by race'}, {'measure': 'Therapeutic actionability', 'timeFrame': 'October 2021', 'description': 'Analysis of actionable alterations by race'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lung adenocarcinoma', 'Next-generation sequencing', 'Tumor genomic profiling', 'Ethnic differences'], 'conditions': ['Adenocarcinoma of Lung']}, 'descriptionModule': {'briefSummary': "Lung adenocarcinomas (LUADs) from Asian ancestry are reported to have different genomic architectures compared with LUADs from Caucasian ancestry. However, due to lack of available cases, few studies controlled the clinical attributes during the comparisons of the genomic alterations. In this study, the investigators will identify Asian LUADs patients who had broad-panel next-generation sequencing (NGS) performed on their primary tumor between January 2018 and December 2019 at the department of thoracic surgery of Peking University People's Hospital. Then, Caucasian LUADs patients who had targeted NGS (Memorial Sloan Kettering-Integrated Mutation Profiling of Actionable Cancer Targets \\[MSK-IMPACT\\]) will be identified in the GENIE database, which consists of 6673 primary lung adenocarcinoma samples with clinical annotations. Finally, genomic alterations regarding somatic mutations, copy number variations, fusions, mutational signatures, oncogenic pathways, and therapeutic actionability will be comprehensively compared between these two cohorts after adjusting age, sex, smoking status, and pathologic stage using propensity score matching. This study will elucidate important ancestry differences between Asian and Caucasian lung adenocarcinoma patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Asian LUADs patients who had broad-panel next-generation sequencing (NGS) performed on their primary tumor between January 2018 and December 2019 at the department of thoracic surgery of Peking University People's Hospital.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary lung adenocarcinoma\n* Broad-panel next-generation sequencing\n* Asian\n\nExclusion Criteria:\n\n* Inadequate clinicopathological information\n* Low-quality next-generation sequencing'}, 'identificationModule': {'nctId': 'NCT04692935', 'briefTitle': 'Comparative Genomic Profiling of Lung Adenocarcinoma in Asians and Caucasians: A Propensity Matched Analysis', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'Comparative Genomic Profiling of Lung Adenocarcinoma in Asians and Caucasians: A Propensity Matched Analysis', 'orgStudyIdInfo': {'id': '2020PHB375'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Asian lung adenocarcinoma', 'description': "Asian LUADs patients who had broad-panel next-generation sequencing (NGS) performed on their primary tumor between January 2018 and December 2019 at the department of thoracic surgery of Peking University People's Hospital"}, {'label': 'Caucasian lung adenocarcinoma', 'description': 'Caucasian LUADs patients who had targeted NGS (Memorial Sloan Kettering-Integrated Mutation Profiling of Actionable Cancer Targets \\[MSK-IMPACT\\]) will be identified in the AACR GENIE database, which consists of 6673 primary lung adenocarcinoma samples with clinical annotations'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jian Zhou, MD', 'role': 'CONTACT', 'email': 'zhoujianmd@hotmail.com', 'phone': '010-88326650'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jun Wang', 'class': 'OTHER'}, 'collaborators': [{'name': 'Berry Genomics Co., Ltd.', 'class': 'INDUSTRY'}, {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jun Wang', 'investigatorAffiliation': "Peking University People's Hospital"}}}}