Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-01-06 @ 3:31 AM
Study NCT ID:
NCT00503958
Status:
UNKNOWN
Last Update Posted:
2013-05-15
First Post:
2007-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Liverpool Lung Project: Risk Factors and Genetic Markers in Healthy Participants and Patients With Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}], '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'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019175', 'term': 'DNA Methylation'}, {'id': 'D020869', 'term': 'Gene Expression Profiling'}, {'id': 'D016021', 'term': 'Epidemiologic Studies'}, {'id': 'D001706', 'term': 'Biopsy'}], 'ancestors': [{'id': 'D008745', 'term': 'Methylation'}, {'id': 'D000478', 'term': 'Alkylation'}, {'id': 'D001669', 'term': 'Biochemical Phenomena'}, {'id': 'D055598', 'term': 'Chemical Phenomena'}, {'id': 'D008660', 'term': 'Metabolism'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D016020', 'term': 'Epidemiologic Study Characteristics'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '1998-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-11', 'lastUpdateSubmitDate': '2013-05-14', 'studyFirstSubmitDate': '2007-07-17', 'studyFirstSubmitQcDate': '2007-07-17', 'lastUpdatePostDateStruct': {'date': '2013-05-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Prepare a molecular genetic and epidemiological risk assessment model based on the analysis of environmental exposures and genetic predisposition, which will provide an algorithm to measure an individual's risk for developing lung cancer"}, {'measure': 'Develop an archive of specimens relating to at-risk individuals and those with lung cancer'}, {'measure': 'Redefine lung cancer based on molecular pathology using the fields of expression and methylation profiling, and genetic instability'}, {'measure': 'Identify and assess novel markers of pre-carcinogenesis in high-risk populations'}, {'measure': 'Facilitate the development of new intervention strategies (i.e., chemoprevention)'}]}, 'conditionsModule': {'keywords': ['non-small cell lung cancer', 'small cell lung cancer', 'health status unknown'], 'conditions': ['Health Status Unknown', 'Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '16273220', 'type': 'BACKGROUND', 'citation': 'Field JK, Smith DL, Duffy S, Cassidy A. The Liverpool Lung Project research protocol. Int J Oncol. 2005 Dec;27(6):1633-45.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Environmental exposure and genetic predisposition may affect the risk of developing cancer later in life. Learning about genetic markers and the long-term effects of environmental exposure may help the study of lung cancer in the future.\n\nPURPOSE: This research study is looking at risk factors and genetic markers in healthy participants and in patients with lung cancer.', 'detailedDescription': "OBJECTIVES:\n\n* To prepare a molecular genetic and epidemiological risk assessment model based on the analysis of environmental exposures and genetic predisposition, which will provide an algorithm to measure an individual's risk for developing lung cancer.\n* To develop an archive of specimens relating to at-risk individuals and those with lung cancer.\n* To redefine lung cancer based on molecular pathology using the fields of expression and methylation profiling, and genetic instability.\n* To identify and assess novel markers of pre-carcinogenesis in our high-risk populations.\n* To facilitate the development of new intervention strategies (i.e., chemoprevention).\n\nOUTLINE: This is a multicenter study.\n\nParticipants and/or patients undergo tumor tissue, sputum, and blood sample collection periodically. Samples are analyzed via fields of expression and methylation profiling and genetic instability. Samples are also archived.\n\nComplete lifetime lifestyle, residential, environmental tobacco smoke, and occupational history are assessed in the first year and then in year five and year ten. Participants who return for follow-up complete a shorter questionnaire aimed at recording change over the interval since their last attendance.\n\nPROJECTED ACCRUAL: 800 patients and 7,500 healthy participants will be accrued for this study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Prospective cohort:\n\n * All residents (n=326,000), aged 45-79, within the designated Liverpool postcode study area will be eligible for entry into the study\n\n * 7,500 people will be randomly selected from this population via general practitioner's (GP's) lists held by each Primary Care Trust\n * All the GP's who have practices within the study area will be asked to collaborate with the project\n* Case-control:\n\n * Patients: Newly diagnosed cases of primary lung cancer\n\n * All cases of epithelial tumors of the trachea, bronchus, and lung will be included\n * Two controls per case who are matched for age (+/- 2 years) and gender and will be randomly selected from the Liverpool Lung Project prospective cohort\n\nPATIENT CHARACTERISTICS:\n\n* Inclusion Criteria:\n\n * Prospective cohort:\n\n * Age 45-79\n * Living within the Liverpool electoral wards\n * Case-control:\n\n * Upper age limit of 80 years old\n * Resident within Liverpool Lung Project area\n* Exclusion Criteria:\n\n * Both cohorts:\n\n * Unable to provide competent informed consent\n * Ineligible to approach based on consultant/clinical team advice\n * Infectious respiratory disease (i.e., chest infection and are on antibiotics) within the past 3 months\n * Untreated pulmonary tuberculosis within the past 3 months\n\nPRIOR CONCURRENT THERAPY:\n\n* Participant and/or patient must not have had any of the following treatments within the last 3 months and is not planning to undergo any of them:\n\n * Cardiac surgery\n * Thoracic surgery\n * Carotid artery surgery\n * Abdominal surgery\n * Chemotherapy\n * Deep x-ray therapy"}, 'identificationModule': {'nctId': 'NCT00503958', 'briefTitle': 'Liverpool Lung Project: Risk Factors and Genetic Markers in Healthy Participants and Patients With Lung Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Liverpool Lung Project', 'orgStudyIdInfo': {'id': 'ULCRC-LLP'}, 'secondaryIdInfos': [{'id': 'CDR0000554297', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'EU-20735'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'DNA methylation analysis', 'type': 'GENETIC'}, {'name': 'DNA stability analysis', 'type': 'GENETIC'}, {'name': 'gene expression analysis', 'type': 'GENETIC'}, {'name': 'epidemiologic study', 'type': 'OTHER'}, {'name': 'study of socioeconomic and demographic variables', 'type': 'OTHER'}, {'name': 'biopsy', 'type': 'PROCEDURE'}, {'name': 'evaluation of cancer risk factors', 'type': 'PROCEDURE'}, {'name': 'study of high risk factors', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L3 9TA', 'city': 'Liverpool', 'state': 'England', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'John K. Field, MA, BDS, PhD, FRCPath', 'role': 'CONTACT', 'phone': '44-151-794-8900'}], 'facility': 'University of Liverpool Cancer Research Centre', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'L9 7AL', 'city': 'Liverpool', 'state': 'England', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '44-151-525-5980'}], 'facility': 'Aintree University Hospital', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'CH63 4JY', 'city': 'Merseyside', 'state': 'England', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Peter Clark, MD', 'role': 'CONTACT', 'email': 'peter.clark@ccotrust.nhs.uk', 'phone': '44-151-482-7828'}], 'facility': 'Clatterbridge Centre for Oncology'}, {'zip': 'L35 5DR', 'city': 'Prescot Merseyside', 'state': 'England', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Ernest Marshall, MD', 'role': 'CONTACT', 'phone': '44-151-426-1600'}], 'facility': 'Whiston Hospital'}, {'zip': 'L14 3PE', 'city': 'Liverpool', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Contact Person', 'role': 'CONTACT', 'phone': '44-151-228-1616'}], 'facility': 'Cardiothoracic Centre - Liverpool', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}], 'overallOfficials': [{'name': 'John K. Field, MA, BDS, PhD, FRCPath', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Liverpool Cancer Research Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Liverpool Cancer Research Centre', 'class': 'OTHER'}}}}