Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2026-01-01 @ 12:00 AM
Study NCT ID:
NCT01914458
Status:
UNKNOWN
Last Update Posted:
2013-08-02
First Post:
2013-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Image Discovering Early Lung Cancer Project
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'lastUpdateSubmitDate': '2013-07-31', 'studyFirstSubmitDate': '2013-07-28', 'studyFirstSubmitQcDate': '2013-07-31', 'lastUpdatePostDateStruct': {'date': '2013-08-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Coronary artery calcification', 'timeFrame': '3 months', 'description': 'Estimate coronary artery calcification score (Agatston Score)in the screened group.'}, {'measure': 'Incidence rate of cardiovascular accident', 'timeFrame': '5 years', 'description': 'Incidence rate of cardiovascular accident stratified by coronary artery calcification score in the screened group within next 5 years.'}, {'measure': 'Diagnosis accuracy of COPD diagnosis by low-dose computed tomography(CT)', 'timeFrame': '2 years', 'description': 'Assess diagnosis accuracy of COPD diagnosis by low-dose computed tomography(CT) (CT emphysema, CT air trapping) according to the reference standard of pulmonary function tests.'}, {'measure': 'Lung nodules management', 'timeFrame': '12 months', 'description': 'Assess algorithms for lung nodules management in a regional general hospital in Taiwan.'}, {'measure': 'Frequency of diagnostic procedures', 'timeFrame': '12 months', 'description': 'Estimate the frequency of diagnostic procedures, types of invasive and non-invasive procedures performed in a regional hospital in Taiwan.'}, {'measure': 'Complication of diagnostic procedures', 'timeFrame': '12 months', 'description': 'Assess the complication rate after diagnostic procedures performed after screening in a regional hospital in Taiwan. Procedures include baseline LDCT.'}], 'primaryOutcomes': [{'measure': 'Lung cancer detection rate', 'timeFrame': '2 years', 'description': 'Assess number of lung cancer diagnoses after radiological and morphological verification of positive lung nodules.'}], 'secondaryOutcomes': [{'measure': 'Lung cancer mortality', 'timeFrame': '5 years', 'description': 'Assess lung cancer mortality in the screened group within next 5 years.'}, {'measure': 'All-cause mortality', 'timeFrame': '5 years', 'description': 'Assess all-cause mortality mortality within next 5 years.'}, {'measure': 'Nodule detection rate', 'timeFrame': '3 months', 'description': 'Estimate nodule detection rate, types (solid, part-solid, or ground glass opacity) and sizes of lung nodules found.'}, {'measure': 'Smoking cessation rate', 'timeFrame': 'one year', 'description': 'Assess smoking cessation rate in the screened group within next one year.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Lung cancer', 'Low-dose computed tomography scan'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Lung cancer is the leading cause of cancer related death in Taiwan and world wide. The application of low dose helical computed tomography (CT) has been the milestone of lung cancer screening. Recently, The National Lung Screening Trial (NLST) shows screening with low-dose CT could reduce mortality from lung cancer. We conducted this clinical trial to determine the efficacy of low dose CT in early lung cancer screening in Taiwan.', 'detailedDescription': 'This is a single center, single arm, non-randomized prospective study. We plan to enroll persons between 50 and 74 years in age, who had cigarette smoking of at least 30 pack-years, and, if former smokers, had quit within the previous 15 years. Persons who had previously received a diagnosis of lung cancer, had undergone chest CT within 18 months before enrollment, had hemoptysis, or had an unexplained weight loss of more than 6.8 kg in the preceding year were excluded.\n\nAll the participants should complete a questionnaire that covers many topics, including demographic characteristics and smoking behavior. We also plan to collect additional data for planned analyses of cost-effectiveness, and smoking cessation. Lung-cancer got by biopsy and other biospecimens are available to researchers through a peer-review process All screening examinations are planed to perform in accordance with a standard protocol, developed by medical physicists associated with the trial, that specified acceptable characteristics of the machine and acquisition variables. All low-dose CT scans are acquired with the use of multidetector scanners with a minimum of 16 channels.\n\nIDEALCAP radiologists are certified by appropriate agencies or boards and has completed training in image acquisition; radiologists also has completed training in image quality and standardized image interpretation. Images are interpreted first in isolation and then in comparison with available historical images and images from prior IDEALCAP screening examinations.\n\nIDEALCAP primary analysis is the detection rate of lung cancer. Secondary analysis include the detection rate of lung nodule, 5-year survival rate of persons with lung cancer who receive standard surgical treatment, 5-year survival rate of persons with lung cancer who receive alternative treatment other than standard surgical treatment (ex. Radiotherapy, chemotherapy or target therapy), the correlation of CT images and cigarette smoking history, the correlation of CT images and pulmonary function.\n\nKey Word： low dose computed-tomography (LDCT), lung cancer screening'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 50-74 years\n* 30 or more pack-years of cigarette smoking history\n* Former smokers: quit smoking within the previous 15 years\n* Ability to tolerate CT procedure\n* Signed informed consent\n\nExclusion Criteria:\n\n* Severe uncontrolled heart, vascular, respiratory or endocrine pathology.\n* Life-expectancy less than 1 year\n* History of lung cancer\n* Acute respiratory disease\n* Hemoptysis.\n* Weight loss more than 6.8 kg in the 12 months prior to eligibility assessment\n* Participation in other cancer clinical trial\n* Chest CT examination in the 12 months prior to eligibility assessment.'}, 'identificationModule': {'nctId': 'NCT01914458', 'acronym': 'IDEALCAP', 'briefTitle': 'Image Discovering Early Lung Cancer Project', 'organization': {'class': 'OTHER', 'fullName': 'Cathay General Hospital'}, 'officialTitle': 'Low-Dose Computed Tomography for Lung Cancer Screening in High Risk Asymptomatic Patients: the Taiwan Study', 'orgStudyIdInfo': {'id': 'CGH-LP101004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low-dose computed tomography (LDCT)', 'description': 'Patients will have one baseline LDCT scan.', 'interventionNames': ['Procedure: Low-dose computed tomography (LDCT)']}], 'interventions': [{'name': 'Low-dose computed tomography (LDCT)', 'type': 'PROCEDURE', 'otherNames': ['LDCT scan'], 'description': 'Low-dose computed tomography scan', 'armGroupLabels': ['Low-dose computed tomography (LDCT)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Luodong', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Chung-Huang Hubert Chan, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Lotung Pohai General hospital', 'geoPoint': {'lat': 24.67727, 'lon': 121.77115}}], 'centralContacts': [{'name': 'Chung-Huang Chan, Doctor', 'role': 'CONTACT', 'email': 'chchantaipei@gmail.com', 'phone': '886-3-9543131', 'phoneExt': '3030'}, {'name': 'Wei-Chun Lin, Doctor', 'role': 'CONTACT', 'email': 'bizzarefish@yahoo.com.tw', 'phone': '886-3-9543131', 'phoneExt': '2430'}], 'overallOfficials': [{'name': 'Chung-Huang Hubert Chan, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CH Chan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cathay General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'CGHIRB', 'investigatorFullName': 'Cathay General Hosp. IRB', 'investigatorAffiliation': 'Cathay General Hospital'}}}}