Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2026-01-10 @ 9:40 AM
Study NCT ID:
NCT03244904
Status:
UNKNOWN
Last Update Posted:
2017-08-10
First Post:
2017-08-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Next-generation Sequencing of Small Cell Lung Cancer to Identify Susceptibility Gene and to Assess Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-08-05', 'studyFirstSubmitDate': '2017-08-05', 'studyFirstSubmitQcDate': '2017-08-05', 'lastUpdatePostDateStruct': {'date': '2017-08-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'sensitive molecular markers for treating', 'timeFrame': '01.11.2017-31.05.2018', 'description': 'during treatment of blood ctDNA for dynamic monitoring, through the mutation type/abundance changes (for example, a typical sample of clonal evolution analysis) and tumor mutation load change, studying whether significant changes of mutations can be used as molecular markers of SCLC'}, {'measure': 'molecular classification of SCLC', 'timeFrame': '01.11.2017-31.05.2018', 'description': 'according to the clinicopathological features of the patients with sclc enrolled , analyzeing molecular classification of SCLC by analyzing mutation types'}], 'primaryOutcomes': [{'measure': 'susceptibility gene site of small cell lung cancer', 'timeFrame': '01.11.2017-31.05.2018', 'description': 'searching susceptibility gene site of small cell lung cancer according to germline mutation data'}], 'secondaryOutcomes': [{'measure': 'consistency of ctDNA and tDNA sequencing results in patients with SCLC', 'timeFrame': '01.11.2017-31.05.2018', 'description': 'explore consistency of ctDNA and tDNA sequencing results in patients with ESCLC'}]}, 'conditionsModule': {'keywords': ['NGS,SCLC, ctDNA'], 'conditions': ['SCLC']}, 'descriptionModule': {'briefSummary': 'Participants will be consented into the study after they are found to meet the study inclusion criteria. The clinical staff will schedule a tissue biopsy and a blood draw for the participant to give NGS(Next-generation Sequencing).One is according to the germline mutation data to screen susceptible gene in SCLC(Small Cell Lung Cancer); two is to explore the extensive consistency detection of blood and tissues in patients with SCLC gene mutation information; three is to conduct dynamic monitoring of blood ctDNA(circulating tumor DNA) in patients with SCLC during treatment, by changing the types of mutations / abundance (for example: the clonal evolution of typical samples analysis) and change of tumor load, , investigating the patients treatment effect , for the significant change of mutations, to study whether it can be used as molecular marker; four is to analyze of the molecular typing of SCLC, according to the clinical and pathological features of patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'SCLC', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients must understand the rigors of the study and provide written informed consent and HIPAA authorization prior to initiation of any study procedures\n* Life expectancy \\> 10 months\n* Karnofsky Performance Status ≥ 70\n* Diagnosis of histological or cytologically confirmed SCLC,\n* Age ≥ 18 years\n* Good medical candidate for and willing to undergo a biopsy or surgical procedure to obtain tissue, which may or may not be part of the patient's routine care for their malignancy.\n\nExclusion Criteria:\n\n* Poor compliance, reluctant to undergo research medication, or follow-up.\n* Tumor inaccessible for biopsy\n* It is currently included in clinical trials of other drugs, or at the same time, into other medical studies that are considered incompatible with the study.\n* It has a history of other cancers, unless the cancer is completely relieved and has not been treated for more than 3 years."}, 'identificationModule': {'nctId': 'NCT03244904', 'briefTitle': 'Next-generation Sequencing of Small Cell Lung Cancer to Identify Susceptibility Gene and to Assess Treatment', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Fujian Cancer Hospital'}, 'officialTitle': 'a Prospective Cohort Study for Small Cell Lung Cancer to Identify Susceptibility Gene and Assess DNA Dynamic Change by Next-generation Sequencing', 'orgStudyIdInfo': {'id': 'CSWOG01'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Gen Lin, MD,PhD', 'role': 'CONTACT', 'email': 'lingen197505@163.com', 'phone': '008613313786157'}], 'overallOfficials': [{'name': 'Gen Lin, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CSWOG'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fujian Cancer Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}