Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2026-01-07 @ 1:30 AM
Study NCT ID:
NCT03172156
Status:
COMPLETED
Last Update Posted:
2024-09-04
First Post:
2017-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ctDNA Dynamic Monitoring and Its Role of Prognosis in Stage I NSCLS by NGS
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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'ctDNA of stage I non-small cell lung cancer (NSCLC)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-01', 'studyFirstSubmitDate': '2017-05-29', 'studyFirstSubmitQcDate': '2017-05-29', 'lastUpdatePostDateStruct': {'date': '2024-09-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease-free survival', 'timeFrame': '2 years after the last patient enrolled', 'description': 'Disease-free survival was assessed from surgery to disease recurrence or death as a result of any cause'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '5 years after the last patient enrolled', 'description': 'Overall survival was assessed from surgery to death as a result of any cause'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NSCLC', 'stage I', 'The next generation of high-throughput gene sequencing (NGS)', 'ctDNA'], 'conditions': ['Non-small Cell Lung Cancer Stage I']}, 'referencesModule': {'references': [{'pmid': '32623075', 'type': 'DERIVED', 'citation': 'Yang W, You N, Jia M, Yeung SJ, Ou W, Yu M, Wang Y, Fu X, Zhang Z, Yang J, Lao Z, Liu Z, Zeng B, Ou Q, Wu X, Shao YW, Hong X, Wang S, Cheng C. Undetectable circulating tumor DNA levels correlate with low risk of recurrence/metastasis in postoperative pathologic stage I lung adenocarcinoma patients. Lung Cancer. 2020 Aug;146:327-334. doi: 10.1016/j.lungcan.2020.06.009. Epub 2020 Jun 20.'}]}, 'descriptionModule': {'briefSummary': 'CtDNA detection is a noninvasive detection method, and the second generation of high-throughput gene sequencing (NGS) is an important means of detecting ctDNA, which can detect trace ctDNA from smaller plasma samples. This project is to study the role of ctDNA dynamic monitoring of stage I NSCLC by NGS technique to verify the prognostic predictive effect of ctDNA .', 'detailedDescription': 'CtDNA detection as a noninvasive detection method, can truly reflect the real tumor tissue gene mutation map and frequency, is the evaluation of therapeutic effect and the important monitoring indicators of clinical follow-up after treatment. The second generation of high-throughput gene sequencing (NGS) is an important means of detecting ctDNA, which can detect trace ctDNA from smaller plasma samples. The ctDNA dynamic monitoring of stage I non-small cell lung cancer (NSCLC) was performed by the second generation gene sequencing (NGS) technique to verify the prognostic predictive effect of ctDNA in stage I NSCLC patients without radiotherapy and targeted therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients With Stage I Non-small Cell Lung Cancer (NSCLC) without Postoperative radiotherapy and chemotherapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postoperative histopathological diagnosis of TNM stage IA / IB NSCLC with R0 resection;\n* No adjuvant chemotherapy, radiotherapy, targeted drug therapy or biotherapy after surgery;\n\nGeneral selection criteria:\n\n* Men or women of age ≥18 years and \\<75 years old;\n* ECOG behavior status score 0 to 1;\n\nExclusion Criteria:\n\n* Patients with other cancers other than NSCLC within five years prior to this study;\n* who can not get enough tumor histological specimens (non-cytological) for analysis;\n* human immunodeficiency virus (HIV) infection;\n* NSCLC mixed with patients with small cell lung cancer;\n* pregnant or lactating women;\n* There is a clear history of neurological or mental disorders, including epilepsy or dementia;\n* Conditions that investigators think is not suitable for inclusion.'}, 'identificationModule': {'nctId': 'NCT03172156', 'briefTitle': 'ctDNA Dynamic Monitoring and Its Role of Prognosis in Stage I NSCLS by NGS', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Multicentre, Prospective, Open Clinical Study of Postoperative ctDNA Dynamic Monitoring and Its Role of Prognosis in Patients With Stage I Non-small Cell Lung Cancer (NSCLC) Using Secondary Gene Sequencing (NGS)', 'orgStudyIdInfo': {'id': 'GASTO1018'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Stage I NSCLC patients after surgery with ctDNA detection', 'description': 'Stage I NSCLC patients;ctDNA detection', 'interventionNames': ['Genetic: ctDNA detection']}], 'interventions': [{'name': 'ctDNA detection', 'type': 'GENETIC', 'description': 'To detect ctDNA in Patients With Stage I Non-small Cell Lung Cancer (NSCLC) Using Secondary Gene Sequencing (NGS)', 'armGroupLabels': ['Stage I NSCLC patients after surgery with ctDNA detection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Si-Yu Wang', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'The investigators will not share IPD to other researchers until initial experimental conclusions is reached.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'First Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Si-Yu Wang', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}