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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02603627
• Other study ID #: RJ115/N106
• Secondary ID: 15/YH/0091
• Status: Not yet recruiting
• Phase: N/A
• First received: August 11, 2015
• Last updated: November 10, 2015
• Start date: December 2015

Study information

• Verified date: October 2015
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: Alex Cumberworth, BM BS BSc
• Email: alex.cumberworth[@]me.com
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Ecologic or Community, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• COPD
• Lung Cancer
• Lung Neoplasms
• Pulmonary Disease, Chronic Obstructive
• Smoking

Locations

Country	Name	City	State
United Kingdom	Guy's and St Thomas' NHS Foundation Trust	London	England

Sponsors (1)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of COPD in lung cancer compared to controls, using spirometry to diagnose COPD.		Up to nine months	No
Secondary	Comparison of the proportion of small cell tumours to non-small cell tumours in patients with lung cancer and COPD.	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.	Up to nine months	No
Secondary	Comparison of the proportion of individuals with an emphysematous phenotype to the proportion of individuals with a bronchitic phenotype.	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.	Up to nine months	No