NCT02603627

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 13, 2015

Completed
18 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Last Updated

November 13, 2015

Status Verified

October 1, 2015

Enrollment Period

8 months

First QC Date

August 11, 2015

Last Update Submit

November 10, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Prevalence of COPD in lung cancer compared to controls, using spirometry to diagnose COPD.

    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.

    Up to nine months

  • Comparison of the proportion of individuals with an emphysematous phenotype to the proportion of individuals with a bronchitic phenotype.

    Up to nine months

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guy's and St Thomas' NHS Foundation Trust

London, England, SE1 9RT, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveLung NeoplasmsSmoking

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsBehavior

Study Officials

  • Tariq Sethi, MBBS PhD

    King's Health Partners

    PRINCIPAL INVESTIGATOR
  • Anthony Dorr, MBBS PhD

    Guy's and St Thomas' NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alex Cumberworth, BM BS BSc

CONTACT

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2015

First Posted

November 13, 2015

Study Start

December 1, 2015

Primary Completion

August 1, 2016

Last Updated

November 13, 2015

Record last verified: 2015-10

Locations