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Prevalence of COPD in Our Lung Cancer Population, Compared to Controls

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ClinicalTrials.gov Identifier: NCT02603627
Recruitment Status : Unknown
Verified October 2015 by Guy's and St Thomas' NHS Foundation Trust.
Recruitment status was:  Not yet recruiting
First Posted : November 13, 2015
Last Update Posted : November 13, 2015
Sponsor:
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

Brief Summary:
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.

Condition or disease
COPD Lung Cancer Smoking

Detailed Description:

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.

COPD is diagnosed by testing lung function, usually using a small device called a spirometer.

COPD 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.

The 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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: Cross-sectional Study to Compare the Prevalence of Chronic Obstructive Pulmonary Disease (COPD) in Patients Newly Diagnosed With Lung Cancer, Compared to Controls
Study Start Date : December 2015
Estimated Primary Completion Date : August 2016


Group/Cohort
With lung cancer
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.
Without lung cancer
Smokers who are referred to the smoking cessation clinic will be invited to undergo spirometry to ascertain the prevalence of COPD in this group.



Primary Outcome Measures :
  1. Prevalence of COPD in lung cancer compared to controls, using spirometry to diagnose COPD. [ Time Frame: Up to nine months ]

Secondary Outcome Measures :
  1. Comparison of the proportion of small cell tumours to non-small cell tumours in patients with lung cancer and COPD. [ Time Frame: Up to nine months ]
    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.

  2. Comparison of the proportion of individuals with an emphysematous phenotype to the proportion of individuals with a bronchitic phenotype. [ Time Frame: Up to nine months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients will be recruited from the multidisciplinary lung cancer clinic at Guy's Hospital.

Controls will be recruited from the smoking cessation clinic at Guy's and St Thomas' NHS Foundation Trust.

Criteria

Inclusion Criteria:

  • Informed consent
  • Aged over 18
  • Lung cancer group: new diagnosis of lung cancer, with spirometry results available Control group: spirometry result available or obtained

Exclusion Criteria:

  • Patient refusal
  • Age under 18
  • Control group: pre-existing lung cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02603627


Contacts
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Contact: Alex Cumberworth, BM BS BSc alex.cumberworth@me.com

Locations
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United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, England, United Kingdom, SE1 9RT
Contact: Tariq Sethi, MBBS PhD    02032993165      
Principal Investigator: Anthony Dorr, MBBS PhD         
Principal Investigator: Tariq Sethi, MBBS PhD         
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
Investigators
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Principal Investigator: Tariq Sethi, MBBS PhD King's Health Partners
Principal Investigator: Anthony Dorr, MBBS PhD Guy's and St Thomas' NHS Foundation Trust
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Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02603627    
Other Study ID Numbers: RJ115/N106
15/YH/0091 ( Other Identifier: Yorkshire and the Humber REC )
First Posted: November 13, 2015    Key Record Dates
Last Update Posted: November 13, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases