Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-01-04 @ 9:35 PM
Study NCT ID:
NCT02833467
Status:
UNKNOWN
Last Update Posted:
2019-08-28
First Post:
2016-07-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identifying Genomic Mutations of Multiple Primary Lung Cancers by Circulating Tumor DNA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}], 'ancestors': [{'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Fresh tumor tissue, peripheral blood cells, and plasma samples were collected from each patient.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-26', 'studyFirstSubmitDate': '2016-07-09', 'studyFirstSubmitQcDate': '2016-07-12', 'lastUpdatePostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The detection rate of cancer related genes in multiple primary lung cancer patients by targeted next generation sequencing', 'timeFrame': '18 months'}], 'secondaryOutcomes': [{'measure': 'The concordant and discordant frequency of genomic results between tumor tissue and circulating tumor DNA in multiple primary lung cancer patients', 'timeFrame': '18 months'}, {'measure': 'The relationship between disease free survival and genomic results in multiple primary lung cancer patients', 'timeFrame': '5 years'}, {'measure': 'The relationship between overall survival and genomic results in multiple primary lung cancer patients', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Circulating Tumor DNA', 'Heterogeneous', 'Multiple primary lung cancer'], 'conditions': ['Carcinoma', 'Non-small-cell Lung Cancer', 'Thoracic Neoplasms']}, 'descriptionModule': {'briefSummary': 'Targeted next generation sequencing (NGS) provides a promising method for diagnostic purposes by enabling the simultaneous detection of multiple gene mutations. This study is to evaluate the feasibility and application value by using NGS into identifying genomic mutations in multiple or multifocal primary lung cancers in cell-tumor DNA (ctDNA) from surgical patients', 'detailedDescription': 'Tumor samples originating from clinically considered multiple or multifocal primary lung cancer patients were available for mutational analysis. DNA and RNA were extracted from fresh tumor tissue or formalin-fixed, paraffin-embedded (FFPE) tissue. A series of cancer-related genomic alterations including single nucleotide variations (SNVs), short insertions and deletions (InDels), copy number variations (CNVs) and gene rearrangements were identified by a comprehensive NGS Panal . High frequency mutations were also identified in blood sample by droplet digital polymerase chain reaction(ddPCR).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Multiple or multifocal primary lung cancer patients who underwent surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must have given written informed consent\n* Histopathologically confirmed NSCLC\n* Considered multiple or multifocal primary lung cancer by clinical criteria\n\nExclusion Criteria:\n\n* Malignant tumor history within the past 5 years\n* Patients who received any treatment prior to resection\n* Insufficient tumor tissue or blood sample'}, 'identificationModule': {'nctId': 'NCT02833467', 'briefTitle': 'Identifying Genomic Mutations of Multiple Primary Lung Cancers by Circulating Tumor DNA', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'A Prospective Study of Identifying Genomic Mutations of Multiple Primary Lung Cancers by Circulating Tumor DNA', 'orgStudyIdInfo': {'id': 'PTHO1502'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Kezhong Chen, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Peking University People's Hospital"}, {'name': 'Jun Wang, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': "Peking University People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'San Valley Biotechnology Incorporated', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD，Thoracic Surgery Service', 'investigatorFullName': 'Chen KeZhong', 'investigatorAffiliation': "Peking University People's Hospital"}}}}