COPDNCT02603627
Prevalence of COPD in Our Lung Cancer Population, Compared to Controls
An observational study of COPD and Lung Cancer, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD, Lung Cancer, Smoking
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2015to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Informed consent
- Aged over 18
- Lung cancer group: new diagnosis of lung cancer, with spirometry results available Control group: spirometry result available or obtained
Who cannot join
- Patient refusal
- Age under 18
- Control group: pre-existing lung cancer
Trial locations and contacts
1 site in 1 country.
Alex Cumberworth, BM BS BSc contact
United Kingdom1 site
Guy's and St Thomas' NHS Foundation Trust
London, England, SE1 9RT
Tariq Sethi, MBBS PhD, 02032993165
Anthony Dorr, MBBS PhD
About this study
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
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.
Read the 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.
- Conditions
- COPD, Lung Cancer, Smoking
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Neoplasms, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of COPD in lung cancer compared to controls, using spirometry to diagnose COPD.
Measured: Up to nine months
Secondary outcomes (2)
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.
Measured: Up to nine months
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.
Measured: Up to nine months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study startDec 2015
- Primary completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tariq Sethi, MBBS PhD, Principal investigator, King's Health PartnersAnthony Dorr, MBBS PhD, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02603627
- Sponsor's protocol ID
- RJ115/N106
- Other IDs
- 15/YH/0091
- Status last verified
- Oct 2015
- First submitted
- 11 Aug 2015
- Last updated
- 13 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02603627
- Acronym / sponsor ID
- RJ115/N106
- Conditions
- COPD, Lung Cancer, Smoking
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Aug 2016 (estimated)
- First posted
- 13 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Informed consent
- Aged over 18
- Lung cancer group: new diagnosis of lung cancer, with spirometry results available Control group: spirometry result available or obtained
Key exclusion criteria (3 listed)
- Patient refusal
- Age under 18
- Control group: pre-existing lung cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of COPD in lung cancer compared to controls, using spirometry to diagnose COPD.
Time frame: Up to nine months
2 secondary outcomes
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alex Cumberworth, BM BS BSc contact
Tariq Sethi, MBBS PhD principal investigator
King's Health Partners
Anthony Dorr, MBBS PhD principal investigator
Guy's and St Thomas' NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and Lung Cancer, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alex Cumberworth, BM BS BSc (alex.cumberworth@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of COPD in lung cancer compared to controls, using spirometry to diagnose COPD. (time frame: Up to nine months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2015.