Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-02 @ 8:05 AM
Study NCT ID:
NCT03805256
Status:
UNKNOWN
Last Update Posted:
2019-01-15
First Post:
2019-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative and Postoperative ctDNA Comparison in Early Stage Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-12', 'studyFirstSubmitDate': '2019-01-12', 'studyFirstSubmitQcDate': '2019-01-12', 'lastUpdatePostDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The potential value of ctDNA in the diagnosis of NSCLC', 'timeFrame': 'Half a year', 'description': 'The sensitivity,specificity,positive predictive valueand the negative predictive value of mutations in plasma ctDNA for detecting early-stage lung cancer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Preoperative and Postoperative ctDNA Comparison in Early Stage Lung Cnacer']}, 'descriptionModule': {'briefSummary': 'Mutation-positive peripheral blood ctDNA became mutation-negative after surgical removal of the cancer tissue. All subjects in the control group were negative for ctDNA mutations。'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The target population comprises all adult patients aged 18 years and older who present with pulmonary nodules.The study sample will include 60 subjects.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:Patients with pulmonary nodules who underwent curative-intent resection were able to enter the study -\n\nExclusion Criteria:Patients who received any invasive examination or treatment prior to resection or had a history of malignancy; patients who do not attend follow up after surgery; blood samples that were contaminated; and biopsies that exhibited advanced lung cancer in pathology。\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03805256', 'briefTitle': 'Preoperative and Postoperative ctDNA Comparison in Early Stage Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital of Soochow University'}, 'officialTitle': 'Preoperative and Postoperative ctDNA Comparison in Early Stage Lung Cancer', 'orgStudyIdInfo': {'id': '12345'}}, 'contactsLocationsModule': {'locations': [{'zip': '215000', 'city': 'Suzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianping Gong, Doctor', 'role': 'CONTACT', 'email': 'gongjianpingsz@162.com', 'phone': '051267783834'}, {'name': 'Mengqin Xu, Master', 'role': 'CONTACT', 'email': 'xumengqin77@163.com', 'phone': '18306202242'}], 'facility': 'Jianping Gong', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}], 'centralContacts': [{'name': 'Jianping chief physician, Doctor', 'role': 'CONTACT', 'email': 'gongjianpingsz@126.com', 'phone': '13701415049'}, {'name': 'Mengqin Xu, Master', 'role': 'CONTACT', 'email': 'xumengqin77@163.com', 'phone': '18306202242'}], 'overallOfficials': [{'name': 'Jianping Gong, Doctor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Second Affiliated Hospital of Soochow University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital of Soochow University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}