Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-26 @ 4:54 PM
Study NCT ID:
NCT01192256
Status:
COMPLETED
Last Update Posted:
2022-08-04
First Post:
2010-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Studies Examining the Importance of Smoking After Being Diagnosed With Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012907', 'term': 'Smoking'}], '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': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-02', 'studyFirstSubmitDate': '2010-08-27', 'studyFirstSubmitQcDate': '2010-08-31', 'lastUpdatePostDateStruct': {'date': '2022-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Median and 2-year survival rates in confirmed smokers versus non- smokers newly diagnosed with lung cancer.', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'Median survival and 2-year survival rates by smoking status for early (Stage I/II NSCLC) versus those with advanced (Stage III/IV) NSCLC.', 'timeFrame': '24 months'}, {'measure': 'Number of treatment complications in smokers versus non-smokers (frequency surgical wound complications, radiotherapy induced pneumonitis and median total radiation (Gy) dose; frequency and duration of neutropenic sepses', 'timeFrame': '2 years'}, {'measure': 'Point prevalence of smoking at 0, 3, 6 12, 24 months', 'timeFrame': '2 years'}, {'measure': 'Comparison of changes in health related quality of life (EQ5D) in smokers versus non-smokers', 'timeFrame': '2 years'}, {'measure': 'Accrual and attendance rates of lung cancer patients attending a hospital smoking cessation service', 'timeFrame': '2 years'}, {'measure': 'Estimate of cost per quality adjusted life year gained by smoking cessation advice in both quit strategies for smokers', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['smoking', 'cessation', 'mortality', 'quality of life'], 'conditions': ['Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '30797485', 'type': 'RESULT', 'citation': 'Gemine RE, Ghosal R, Collier G, Parry D, Campbell I, Davies G, Davies K, Lewis KE; LungCast Investigators. Longitudinal study to assess impact of smoking at diagnosis and quitting on 1-year survival for people with non-small cell lung cancer. Lung Cancer. 2019 Mar;129:1-7. doi: 10.1016/j.lungcan.2018.12.028. Epub 2018 Dec 28.'}, {'pmid': '37820539', 'type': 'DERIVED', 'citation': 'Gemine RE, Davies GR, Lanyon K, Rees SE, Campbell I, Lewis KE; LungCAST Investigators. Quitting smoking improves two-year survival after a diagnosis of non-small cell lung cancer. Lung Cancer. 2023 Dec;186:107388. doi: 10.1016/j.lungcan.2023.107388. Epub 2023 Oct 1.'}, {'pmid': '37059391', 'type': 'DERIVED', 'citation': 'Jones M, Lowin J, Sewell B, Gemine RE, Rees SE, Lanyon K, Lewis KE. The Economic Potential of Smoking Cessation Interventions at the Point of Diagnosis of Non-Small Cell Lung Cancer. Value Health. 2023 Aug;26(8):1192-1200. doi: 10.1016/j.jval.2023.03.2429. Epub 2023 Apr 12.'}]}, 'descriptionModule': {'briefSummary': 'A large project consisting of:\n\na) an observational trial where smoking status is recorded on 1400 consecutive people newly diagnosed with lung cancer. Smoking status is biologically validated with exhaled carbon monoxide (eCO) levels every 3 months. Survival, cancer progression and treatment complications will be recorded and compared in smokers, ex-smokers and never smokers.', 'detailedDescription': 'Smoking causes around 85% of lung cancer. Continued smoking after diagnosis probably worsens survival and increases treatment complications but prospective well-designed studies are lacking.\n\nThis project is an observational cohort study recording outcomes in smokers, never-smokers, and ex-smokers, using exhaled carbon monoxide to validate smoking status when they attend for further lung cancer clinics.\n\nThis project is unique, as every patient with a clinical diagnosis of lung cancer will have their smoking status biologically validated by a quick and easy test, and those enrolled in the smoking cessation treatments or not will also complete a generic quality of life questionnaire at regular intervals. These appointments will coincide with other hospital appointments wherever possible, and survival status will reported up to 24 months after enrolment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with newly diagnosed lung cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of lung cancer\n\nExclusion Criteria:\n\n* refusal Consent\n* inability to provide exhaled CO\n* active psychiatric illness or substance misuse\n* concurrent malignancies of another type other than non-melanoma skin cancer\n* unable to travel for sessions with smoking cessation counsellor and / or outpatient visits from outset\n* WHO performance status 4\n* Life expectancy less than 6 weeks.'}, 'identificationModule': {'nctId': 'NCT01192256', 'acronym': 'LungCast', 'briefTitle': 'Studies Examining the Importance of Smoking After Being Diagnosed With Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Hywel Dda Health Board'}, 'officialTitle': 'Does Smoking Status After Being Diagnosed With Lung Cancer Influence Outcome? An Observational Cohort Study.', 'orgStudyIdInfo': {'id': '09/WMW01/28'}, 'secondaryIdInfos': [{'id': 'WS763986', 'type': 'OTHER_GRANT', 'domain': 'GRAND Pfizer'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cardiff', 'state': 'Wales', 'country': 'United Kingdom', 'facility': 'Llandough Hospital, Cardiff and Vale University Health Board', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'zip': 'SA14 8QF', 'city': 'Llanelli', 'state': 'Wales', 'country': 'United Kingdom', 'facility': 'Hywel Dda Health Board', 'geoPoint': {'lat': 51.68195, 'lon': -4.16191}}], 'overallOfficials': [{'name': 'Keir E Lewis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hywel Dda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr Keir Lewis', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cardiff and Vale University Health Board', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor in Medicine and Consultant Chest Physician', 'investigatorFullName': 'Dr Keir Lewis', 'investigatorAffiliation': 'Hywel Dda Health Board'}}}}