Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2025-12-24 @ 5:29 PM
Study NCT ID:
NCT04220268
Status:
UNKNOWN
Last Update Posted:
2020-01-07
First Post:
2020-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Prospective Cohort of Pulmonary Ground Glass Nodules Patients With Family History.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood and surgical tumor samples of all the participants will be collected. Moreover, blood samples of other family members of participants will be collected, with their consent and knowledge.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2022-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-05', 'studyFirstSubmitDate': '2020-01-05', 'studyFirstSubmitQcDate': '2020-01-05', 'lastUpdatePostDateStruct': {'date': '2020-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The prevalence of family aggregation of pulmonary ground glass nodule.', 'timeFrame': '1 week', 'description': 'To investigate the aggregation of pulmonary ground glass nodule among first-degree relatives of participants via the questionnaire.'}], 'secondaryOutcomes': [{'measure': 'Susceptibility genetic events related to the family aggregation of ground glass nodules.', 'timeFrame': '1 month', 'description': 'To investigate the underlying susceptibility genetic loci which concern with familial inheritance of ground glass nodule.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ground glass nodule', 'Family aggregation', 'Hereditary susceptibility'], 'conditions': ['Lung Neoplasms', 'Family Research']}, 'referencesModule': {'references': [{'pmid': '31326317', 'type': 'BACKGROUND', 'citation': 'Dai J, Lv J, Zhu M, Wang Y, Qin N, Ma H, He YQ, Zhang R, Tan W, Fan J, Wang T, Zheng H, Sun Q, Wang L, Huang M, Ge Z, Yu C, Guo Y, Wang TM, Wang J, Xu L, Wu W, Chen L, Bian Z, Walters R, Millwood IY, Li XZ, Wang X, Hung RJ, Christiani DC, Chen H, Wang M, Wang C, Jiang Y, Chen K, Chen Z, Jin G, Wu T, Lin D, Hu Z, Amos CI, Wu C, Wei Q, Jia WH, Li L, Shen H. Identification of risk loci and a polygenic risk score for lung cancer: a large-scale prospective cohort study in Chinese populations. Lancet Respir Med. 2019 Oct;7(10):881-891. doi: 10.1016/S2213-2600(19)30144-4. Epub 2019 Jul 17.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the present prospective cohort study (GGN-F) is to study the family aggregation of pulmonary ground glass nodules via the questionnaire survey and to investigate the underlying genetic mechanism via the biobank.', 'detailedDescription': 'In recent years, with the development of low-dose chest CT screening, more and more ground glass nodules have been found. Meanwhile, presenting as Ground-glass nodule (GGN), the early-stage lung adenocarcinoma patients with lung cancer family history have been emerging increasing in recent years in East Asian.\n\nThis prospective cohort study, with both a cross-sectional and a longitudinal part, will include patients with pulmonary ground glass nodule, which were proven malignant disease.\n\nAll participants will be asked to complete questionnaire to build the clinical database of GGN patients with detailed family history. Furthermore, blood and surgical tumor samples will be collected as a specific biobank. And the blood samples of other family members of participants will be collected, with their consent and knowledge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All the patients with pulmonary ground glass nodules and pathological proved malignant disease will be enrolled.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. patients with informed consent;\n2. patients with pulmonary ground glass nodule.\n3. pathological proved early stage lung cancer.\n\nExclusion Criteria:\n\n1.not included in the inclusion criteria'}, 'identificationModule': {'nctId': 'NCT04220268', 'acronym': 'GGN-F', 'briefTitle': 'A Prospective Cohort of Pulmonary Ground Glass Nodules Patients With Family History.', 'organization': {'class': 'OTHER', 'fullName': "Guangdong Provincial People's Hospital"}, 'officialTitle': 'Clinical Database and Biobank of Pulmonary Ground Glass Nodules Patients With Family History, a Prospective Cohort Study.', 'orgStudyIdInfo': {'id': 'GGN-family'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants', 'description': 'All the patients with proved malignant ground glass nodule will be enrolled.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jia-Tao Zhang', 'role': 'CONTACT', 'email': '18820792959@163.com', 'phone': '+86-13609777314'}, {'name': 'Wen-Zhao Zhong', 'role': 'CONTACT', 'email': '13609777314@163.com', 'phone': '+86-13609777314'}], 'facility': "Guangdong Provincial People's Hospital", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Jia-Tao Zhang, Ph.D', 'role': 'CONTACT', 'email': '18820792959@163.com', 'phone': '+86-83827812-51311'}, {'name': 'Rui Fu, MD', 'role': 'CONTACT', 'email': '13rfu@stu.edu.cn', 'phone': '+86-83827812-51311'}], 'overallOfficials': [{'name': 'Wenzhao Zhong, Ph。D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Guangdong Provincial People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guangdong Provincial People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Porfessor', 'investigatorFullName': 'Wen-zhao ZHONG', 'investigatorAffiliation': "Guangdong Provincial People's Hospital"}}}}