Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-29 @ 7:57 AM
Study NCT ID:
NCT02941003
Status:
UNKNOWN
Last Update Posted:
2016-10-27
First Post:
2016-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Precision Diagnosis for Intraoperative Frozen Section of Early Stage Lung Cancer
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 540}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2019-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-25', 'studyFirstSubmitDate': '2016-10-19', 'studyFirstSubmitQcDate': '2016-10-19', 'lastUpdatePostDateStruct': {'date': '2016-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of histopathological characteristics between intraoperative frozen section and paraffin section for patients with early stage lung adenocarcinoma', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Detection of CD31/CD34, D2-40, Ki67 and p53 among different subtypes of early stage lung adenocarcinoma by immunohistochemical (IHC) analysis', 'timeFrame': '6 months'}, {'measure': 'Comparison of mutation profiles among different subtypes of early stage lung adenocarcinoma by tissue microdissection and subsequent next generation sequencing (NGS)', 'timeFrame': '6 months'}, {'measure': 'Verification of the driver mutations from NGS results using droplet digital PCR (ddPCR) in early stage lung adenocarcinoma.', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Early stage lung adenocarcinoma', 'Intraoperative frozen section', 'Diagnostic criteria'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is:\n\n1. To establish a set of diagnostic criteria of intraoperative frozen section of early stage lung adenocarcinoma, including clinicopathologic and molecular characteristics.\n2. To assess its clinical usefulness in guiding surgical procedure for early stage lung adenocarcinoma.', 'detailedDescription': 'The detection rate of small pulmonary nodules is increasing due to the widespread use of high-resolution computed tomography (CT) screening in clinical practice. These minute pulmonary nodules are suggestive of atypical adenomatous hyperplasia (AHH), adenocarcinoma in situ (AIS), minimally invasive adenocarcinoma (MIA), and invasive adenocarcinoma. Hence, the precision diagnosis of intraoperative frozen section is particularly imperative for its fundamental role in assess indeterminate lung lesions and guide the extent of subsequent surgical procedure.\n\nHowever, it is still difficult for the surgical pathologist to apply the various features according to the newly revised WHO classification of lung adenocarcinoma (2015) to guide surgical management due to their unascertained accuracy or heterogeneity of lung cancer or technique problem. Therefore, the establishment and assessment for a set of diagnostic criteria of intraoperative frozen section of early stage lung adenocarcinoma are our primary aim in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with suspected pulmonary nodules (5\\~20 mm) by chest CT scan;\n2. Patients received surgical operation.\n\nExclusion Criteria:\n\n1. Patients compliance is poor and cannot accept follow-up;\n2. Patients nursing or pregnant;\n3. Patients with a history of any cancer;\n4. Patients with confirmed pathological diagnosis or received radiotherapy or chemotherapy or target therapy preoperatively.'}, 'identificationModule': {'nctId': 'NCT02941003', 'briefTitle': 'Precision Diagnosis for Intraoperative Frozen Section of Early Stage Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Chest Hospital'}, 'officialTitle': 'Establishment and Evaluation for Pathological Diagnostic Criteria of Intraoperative Frozen Section of Early Stage Lung Cancer', 'orgStudyIdInfo': {'id': 'Chest005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OCT treatment', 'description': 'Randomly assigned patients whose small pulmonary nodules are inflated with the diluted OCT medium (2:3) used for frozen section, and then detected under microscope for their histopathological characteristics, by immunostaining for specific protein expression, by NGS (next-generation sequencing) for driver mutations.', 'interventionNames': ['Device: microscope', 'Other: immunostaining', 'Device: NGS']}, {'type': 'EXPERIMENTAL', 'label': 'OCT free', 'description': 'Randomly assigned patients whose small pulmonary nodules are uninflated with OCT used for frozen section, and then detected under microscope for their histopathological characteristics, by immunostaining for specific protein expression, by NGS for driver mutations.', 'interventionNames': ['Device: microscope', 'Other: immunostaining', 'Device: NGS']}], 'interventions': [{'name': 'microscope', 'type': 'DEVICE', 'description': 'Detection of of histopathological characteristics of OCT treatment or OCT free samples from patients .', 'armGroupLabels': ['OCT free', 'OCT treatment']}, {'name': 'immunostaining', 'type': 'OTHER', 'description': 'Detection of CD31/CD34, D2-40, Ki67 and p53 immunostaining of OCT treatment or OCT free samples from patients .', 'armGroupLabels': ['OCT free', 'OCT treatment']}, {'name': 'NGS', 'type': 'DEVICE', 'otherNames': ['Illumina Nexseq500'], 'description': 'The investigators used the device to detect the gene mutations of OCT treatment or OCT free samples obtained from part of the patients.', 'armGroupLabels': ['OCT free', 'OCT treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200030', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jie Zhang, MD, MS', 'role': 'CONTACT', 'email': '18017321572@163.com', 'phone': '(+86)18017321572'}, {'name': 'Keke Yu, MD, PhD', 'role': 'CONTACT', 'email': 'ykkxx@shchest.org', 'phone': '(+86)18930859590'}], 'facility': 'Shanghai Chest Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Jie Zhang, MD, MS', 'role': 'CONTACT', 'email': '18017321572@163.com', 'phone': '(+86)18017321572'}, {'name': 'Keke Yu, MD, PhD', 'role': 'CONTACT', 'email': 'ykkxx@shchest.org', 'phone': '(+86)18930859590'}], 'overallOfficials': [{'name': 'Jie Zhang, MD, MS.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Chest Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Chest Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Physician', 'investigatorFullName': 'Jie Zhang', 'investigatorAffiliation': 'Shanghai Chest Hospital'}}}}