Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-02-25 @ 8:59 PM
Study NCT ID:
NCT01551251
Status:
COMPLETED
Last Update Posted:
2015-07-28
First Post:
2012-03-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tumor Associated Macrophage in Advanced Non-small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'All specimens were fixed in 10% buffered formalin and embedded in paraffin according to standard procedures. All of the tissues were fixed immediately after biopsy, with time from tissue acquisition to fixation as short as possible. Serial sections (4 μm thickness) placed on positively charged slides (Menzel-Glasser, German) were used for immuno-histochemistry.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 107}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-27', 'studyFirstSubmitDate': '2012-03-08', 'studyFirstSubmitQcDate': '2012-03-09', 'lastUpdatePostDateStruct': {'date': '2015-07-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response to treatment of advanced NSCLC with high or low TAM.', 'timeFrame': '2-3 months', 'description': 'All patients with advanced non-small cell lung cancer (NSCLC) who had been treated were included. The decision of advanced NSCLC treatment was a consensus by the patient and clinician, and approved by team conference (including the oncologists, pulmonologists, pathologists, radiologists, surgeons, radiation oncologists, and nuclear medicine specialists). The tumor response was evaluated using computerized tomography according to the Response Evaluation Criteria in Solid Tumors (RECIST). The treatment response of advanced between high and low TAM patients were compared.'}], 'secondaryOutcomes': [{'measure': 'Outcomes of advanced NSCLC with high and low TAM.', 'timeFrame': '12-24 months', 'description': 'The outcomes of advanced NSCLC with high and low TAM will be compared. The outcomes include overall survival (OS) and progression-free survival (PFS). Survival curves were estimated by the Kaplan-Meier method while the log-rank test was used to compare the patient survival times per groups.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Advanced Nonsmall Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '15598976', 'type': 'BACKGROUND', 'citation': 'Chen JJ, Lin YC, Yao PL, Yuan A, Chen HY, Shun CT, Tsai MF, Chen CH, Yang PC. Tumor-associated macrophages: the double-edged sword in cancer progression. J Clin Oncol. 2005 Feb 10;23(5):953-64. doi: 10.1200/JCO.2005.12.172. Epub 2004 Dec 14.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effects of tumor associated macrophage (TAM) in advanced non-small cell lung cancer (NSCLC) patients on the treatment response and outcome of these subjects. Pathologic specimens from tissue bank will be stained by immunostaining methods with CD68 antibody. The clinical treatment response and outcomes will be analyzed between high or low TAM.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with advanced non-small cell lung cancer (stage IIIb and IV NSCLC) who had been treated at the Linkou Branch of Chang Gung Memorial Hospital between 2006 and 2009 were included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* advanced NSCLC,\n* more than 20 years old,\n* measurable tumor,\n* response and outcome recorded after the first line treatment.\n\nExclusion Criteria:\n\n* Early stage NSCLC,\n* less than 20 years,\n* pregnancy,\n* unmeasurable NSCLC.'}, 'identificationModule': {'nctId': 'NCT01551251', 'briefTitle': 'Tumor Associated Macrophage in Advanced Non-small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'Tumor-Associated Macrophages Correlate With Response and Outcomes in Advanced Non-Small Cell Lung Cancer After First Line Treatment.', 'orgStudyIdInfo': {'id': '100-0522B'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Advanced NSCLC with high TAM', 'description': 'All patients with advanced non-small cell lung cancer who had been treated at the Linkou Branch of Chang Gung Memorial Hospital were included. Tumor specimens with high TAM were included as one cohort group.'}, {'label': 'Advanced NSCLC with low TAM', 'description': 'All patients with advanced non-small cell lung cancer who had been treated at the Linkou Branch of Chang Gung Memorial Hospital were included. Tumor specimens with low TAM were included as one cohort group.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10507', 'city': 'Taipei', 'state': 'Taipei', 'country': 'Taiwan', 'facility': 'Chang Gung Memorial Hospital'}, {'city': 'Taoyuan District', 'country': 'Taiwan', 'facility': 'Sant Paul Hospital', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}], 'overallOfficials': [{'name': 'Fu-Tsai Chung, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chang Gung Memorial Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chang Gung Memorial Hospital', 'investigatorFullName': 'Chung Fu-Tsai', 'investigatorAffiliation': 'Chang Gung Memorial Hospital'}}}}