Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-03-09 @ 2:44 AM
Study NCT ID:
NCT04156360
Status:
UNKNOWN
Last Update Posted:
2019-11-07
First Post:
2019-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Construction and Evaluation of the Liquid Biopsy-based Early Diagnostic Model for Lung Cancer
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': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-05', 'studyFirstSubmitDate': '2019-10-28', 'studyFirstSubmitQcDate': '2019-11-05', 'lastUpdatePostDateStruct': {'date': '2019-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determination of prevalence of CTCs and CAMLs in patients with pulmonary nodules', 'timeFrame': '12 months', 'description': 'The number of CTCs and CAMLs will be detected in the peripheral blood of patients with pulmonary nodules using a novel microfluidic CTC-detection system.'}], 'secondaryOutcomes': [{'measure': 'Determination of optimal cut-off values for screening Lung Cancer paitents', 'timeFrame': '6 months', 'description': 'The optimal cut-off values will be determined by the ROC analyses.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy', 'Pulmonary Nodule']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to detetct Circulating tumor cells(CTCs) and Cancer Associated Macrophage-Like cells (CAMLs) in patients with pulmonary nodules using a novel microfluidic CTC-detection system. Then construct an early diagnostic model for lung cancer.', 'detailedDescription': 'Patients found pulmonary nodules by CT screening will be enrolled in this study prospectively. CTCs and CAMLs both are cancer specific biomarkers found in the peripheral blood of patients with solid tumors including lung cancer. Through detecting CTCs and CAMLs in healthy volunteers and patients with pulmonary nodules who undergo biopsy, determine the cut-off value of the test. Further analysis of the test specificity and sensitivity, and on this basis construct an early diagnostic model for lung cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with pulmonary nodules diagnosed by chest CT or low-dose computed tomography (LDCT) scans', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female or male, 18 years of age or older\n* Pulmonary nodules diagnosed by chest CT or low-dose computed tomography (LDCT) scans\n\nExclusion Criteria:\n\n* Prior diagnosis of lung cancer or other invasive malignancy within the past 5 years'}, 'identificationModule': {'nctId': 'NCT04156360', 'briefTitle': 'Construction and Evaluation of the Liquid Biopsy-based Early Diagnostic Model for Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Pulmonary Hospital, Shanghai, China'}, 'officialTitle': 'Construction and Evaluation of the Liquid Biopsy-based Early Diagnostic Model for Lung Cancer', 'orgStudyIdInfo': {'id': 'YT2019-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy Volunteers'}, {'label': 'Patients With Pulmonary Nodule'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yayi He, MD, PHD', 'role': 'CONTACT', 'email': '2250601@qq.com', 'phone': '+862165115006'}], 'overallOfficials': [{'name': 'Yayi He, MD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Pulmonary Hospital, Tongji University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Pulmonary Hospital, Shanghai, China', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director Head of Medical Oncology', 'investigatorFullName': 'Caicun Zhou', 'investigatorAffiliation': 'Shanghai Pulmonary Hospital, Shanghai, China'}}}}