Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2026-02-25 @ 8:18 PM
Study NCT ID:
NCT02603627
Status:
UNKNOWN
Last Update Posted:
2015-11-13
First Post:
2015-08-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of COPD in Our Lung Cancer Population, Compared to Controls
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'lastUpdateSubmitDate': '2015-11-10', 'studyFirstSubmitDate': '2015-08-11', 'studyFirstSubmitQcDate': '2015-11-10', 'lastUpdatePostDateStruct': {'date': '2015-11-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of COPD in lung cancer compared to controls, using spirometry to diagnose COPD.', 'timeFrame': 'Up to nine months'}], 'secondaryOutcomes': [{'measure': 'Comparison of the proportion of small cell tumours to non-small cell tumours in patients with lung cancer and COPD.', 'timeFrame': 'Up to nine months', 'description': 'No change to routine care (no extra specimens to be taken or retained), but data on the histological subtypes will be recorded (as described above) to better inform the investigators about whether COPD-associated lung cancer demonstrates a different histological subtype.'}, {'measure': 'Comparison of the proportion of individuals with an emphysematous phenotype to the proportion of individuals with a bronchitic phenotype.', 'timeFrame': 'Up to nine months', 'description': 'No change to routine care (no extra investigations to be performed), but data on the radiological phenotype will be recorded to better inform the investigators about whether patients with COPD-associated lung cancer tend to have an emphysematous COPD pattern or a bronchitic one.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['COPD', 'Lung Cancer', 'Smoking']}, 'descriptionModule': {'briefSummary': 'This study will investigate the prevalence of chronic obstructive pulmonary disease (COPD) in patients who are newly diagnosed with lung cancer and compare it to the prevalence of COPD in controls recruited from a smoking cessation clinic.', 'detailedDescription': 'Chronic obstructive pulmonary disease (COPD) is a breathing problem that some people develop. Usually it is caused by smoking. Damage to the lungs means that patients are at risk of more chest infections and are unable to exercise like healthy individuals. They may also have a long-standing cough.\n\nCOPD is diagnosed by testing lung function, usually using a small device called a spirometer.\n\nCOPD is becoming a better understood condition. It is known that the lungs of patients with COPD are sometimes inflamed. This is important because inflammation is associated with some types of cancer, including lung cancer.\n\nThe investigators are interested in whether COPD puts people at higher risk of lung cancer. They would like to find out how common COPD is in patients who have lung cancer. The investigators would also like to find out how common COPD is in patients who are not known to have lung cancer (comparison group). This will help them interpret their results better as investigators will be able to compare the two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients will be recruited from the multidisciplinary lung cancer clinic at Guy's Hospital.\n\nControls will be recruited from the smoking cessation clinic at Guy's and St Thomas' NHS Foundation Trust.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent\n* Aged over 18\n* Lung cancer group: new diagnosis of lung cancer, with spirometry results available Control group: spirometry result available or obtained\n\nExclusion Criteria:\n\n* Patient refusal\n* Age under 18\n* Control group: pre-existing lung cancer'}, 'identificationModule': {'nctId': 'NCT02603627', 'briefTitle': 'Prevalence of COPD in Our Lung Cancer Population, Compared to Controls', 'organization': {'class': 'OTHER', 'fullName': "Guy's and St Thomas' NHS Foundation Trust"}, 'officialTitle': 'Cross-sectional Study to Compare the Prevalence of Chronic Obstructive Pulmonary Disease (COPD) in Patients Newly Diagnosed With Lung Cancer, Compared to Controls', 'orgStudyIdInfo': {'id': 'RJ115/N106'}, 'secondaryIdInfos': [{'id': '15/YH/0091', 'type': 'OTHER', 'domain': 'Yorkshire and the Humber REC'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'With lung cancer', 'description': 'Patients who have a new diagnosis of lung cancer will be invited to undergo spirometry to enable us to gather data on the prevalence of COPD in this group.'}, {'label': 'Without lung cancer', 'description': 'Smokers who are referred to the smoking cessation clinic will be invited to undergo spirometry to ascertain the prevalence of COPD in this group.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE1 9RT', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'contacts': [{'name': 'Tariq Sethi, MBBS PhD', 'role': 'CONTACT', 'phone': '02032993165'}, {'name': 'Anthony Dorr, MBBS PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Tariq Sethi, MBBS PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Guy's and St Thomas' NHS Foundation Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Alex Cumberworth, BM BS BSc', 'role': 'CONTACT', 'email': 'alex.cumberworth@me.com'}], 'overallOfficials': [{'name': 'Tariq Sethi, MBBS PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "King's Health Partners"}, {'name': 'Anthony Dorr, MBBS PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Guy's and St Thomas' NHS Foundation Trust"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guy's and St Thomas' NHS Foundation Trust", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}