Lung CancerLungCastNCT01192256
Studies Examining the Importance of Smoking After Being Diagnosed With Lung Cancer
An observational study of Lung Cancer, run by Dr Keir Lewis at 2 sites in United Kingdom.
Trial summary
A large project consisting of: a) an observational trial where smoking status is recorded on 1400 consecutive people newly diagnosed with lung cancer. Smoking status is biologically validated with exhaled carbon monoxide (eCO) levels every 3 months. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lung Cancer
- How many people
- 2,400 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Mar 2010to 15 Mar 2021
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with newly diagnosed lung cancer
Who may be able to join
- clinical diagnosis of lung cancer
Who cannot join
- refusal Consent
- inability to provide exhaled CO
- active psychiatric illness or substance misuse
- concurrent malignancies of another type other than non-melanoma skin cancer
- unable to travel for sessions with smoking cessation counsellor and / or outpatient visits from outset
- WHO performance status 4
- Life expectancy less than 6 weeks.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Llandough Hospital, Cardiff and Vale University Health Board
Cardiff, Wales
Hywel Dda Health Board
Llanelli, Wales, SA14 8QF
About this study
Official title: Does Smoking Status After Being Diagnosed With Lung Cancer Influence Outcome? An Observational Cohort Study.
A large project consisting of:
- an observational trial where smoking status is recorded on 1400 consecutive people newly diagnosed with lung cancer. Smoking status is biologically validated with exhaled carbon monoxide (eCO) levels every 3 months. Survival, cancer progression and treatment complications will be recorded and compared in smokers, ex-smokers and never smokers.
Read the detailed description
Smoking causes around 85% of lung cancer. Continued smoking after diagnosis probably worsens survival and increases treatment complications but prospective well-designed studies are lacking.
This project is an observational cohort study recording outcomes in smokers, never-smokers, and ex-smokers, using exhaled carbon monoxide to validate smoking status when they attend for further lung cancer clinics.
This project is unique, as every patient with a clinical diagnosis of lung cancer will have their smoking status biologically validated by a quick and easy test, and those enrolled in the smoking cessation treatments or not will also complete a generic quality of life questionnaire at regular intervals. These appointments will coincide with other hospital appointments wherever possible, and survival status will reported up to 24 months after enrolment.
- Conditions
- Lung Cancer
- Keywords
- smoking, cessation, mortality, quality of life
- Medical subject headings
- Lung Neoplasms, Smoking
What is being measured
The primary outcome is the main question the study is designed to answer.
Median and 2-year survival rates in confirmed smokers versus non- smokers newly diagnosed with lung cancer.
Measured: 24 months
Secondary outcomes (6)
Median survival and 2-year survival rates by smoking status for early (Stage I/II NSCLC) versus those with advanced (Stage III/IV) NSCLC.
Measured: 24 months
Number of treatment complications in smokers versus non-smokers (frequency surgical wound complications, radiotherapy induced pneumonitis and median total radiation (Gy) dose; frequency and duration of neutropenic sepses
Measured: 2 years
Point prevalence of smoking at 0, 3, 6 12, 24 months
Measured: 2 years
Comparison of changes in health related quality of life (EQ5D) in smokers versus non-smokers
Measured: 2 years
Accrual and attendance rates of lung cancer patients attending a hospital smoking cessation service
Measured: 2 years
Estimate of cost per quality adjusted life year gained by smoking cessation advice in both quit strategies for smokers
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2010 (estimated)
- Study startMar 2010
- Primary completion15 Mar 2021
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Keir Lewis
- Sponsor type
- University, hospital or other
- Collaborators
- Cardiff and Vale University Health Board
- Responsible party
- Sponsor-investigator, Dr Keir Lewis, Hywel Dda Health Board
- Investigators
- Keir E Lewis, MD, Principal investigator, Hywel Dda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01192256
- Sponsor's protocol ID
- 09/WMW01/28
- Other IDs
- WS763986
- Acronym
- LungCast
- Status last verified
- Aug 2022
- First submitted
- 27 Aug 2010
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gemine RE, Ghosal R, Collier G, Parry D, Campbell I, Davies G, Davies K, Lewis KE; LungCast Investigators. Longitudinal study to assess impact of smoking at diagnosis and quitting on 1-year survival for people with non-small cell lung cancer. Lung Cancer. 2019 Mar;129:1-7. doi: 10.1016/j.lungcan.2018.12.028. Epub 2018 Dec 28.
PubMed 30797485Gemine RE, Davies GR, Lewis KE; LungCAST Investigators. Quitting Smoking and Two-Year Survival After a Diagnosis of Small-Cell Lung Cancer. Clin Lung Cancer. 2026 Jun 27;27(7):18-23. doi: 10.1016/j.cllc.2026.06.006. Online ahead of print.
PubMed 42480249Gemine RE, Davies GR, Lanyon K, Rees SE, Campbell I, Lewis KE; LungCAST Investigators. Quitting smoking improves two-year survival after a diagnosis of non-small cell lung cancer. Lung Cancer. 2023 Dec;186:107388. doi: 10.1016/j.lungcan.2023.107388. Epub 2023 Oct 1.
PubMed 37820539Jones M, Lowin J, Sewell B, Gemine RE, Rees SE, Lanyon K, Lewis KE. The Economic Potential of Smoking Cessation Interventions at the Point of Diagnosis of Non-Small Cell Lung Cancer. Value Health. 2023 Aug;26(8):1192-1200. doi: 10.1016/j.jval.2023.03.2429. Epub 2023 Apr 12.
PubMed 37059391
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Smoking Status After Being Diagnosed With Lung Cancer Influence Outcome? An Observational Cohort Study.
- ClinicalTrials.gov ID
- NCT01192256
- Acronym / sponsor ID
- LungCast / 09/WMW01/28
- Conditions
- Lung Cancer
- Keywords
- smoking, cessation, mortality, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,400 participants (actual)
- Lead sponsor
- Dr Keir LewisUniversity, hospital or other
- Collaborators
- Cardiff and Vale University Health Board
- Study start
- Mar 2010 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 1 Sep 2010 (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.
A large project consisting of:
- an observational trial where smoking status is recorded on 1400 consecutive people newly diagnosed with lung cancer. Smoking status is biologically validated with exhaled carbon monoxide (eCO) levels every 3 months. Survival, cancer progression and treatment complications will be recorded and compared in smokers, ex-smokers and never smokers.
Detailed description
Smoking causes around 85% of lung cancer. Continued smoking after diagnosis probably worsens survival and increases treatment complications but prospective well-designed studies are lacking.
This project is an observational cohort study recording outcomes in smokers, never-smokers, and ex-smokers, using exhaled carbon monoxide to validate smoking status when they attend for further lung cancer clinics.
This project is unique, as every patient with a clinical diagnosis of lung cancer will have their smoking status biologically validated by a quick and easy test, and those enrolled in the smoking cessation treatments or not will also complete a generic quality of life questionnaire at regular intervals. These appointments will coincide with other hospital appointments wherever possible, and survival status will reported up to 24 months after enrolment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with newly diagnosed lung cancer
Key inclusion criteria (1 listed)
- clinical diagnosis of lung cancer
Key exclusion criteria (7 listed)
- refusal Consent
- inability to provide exhaled CO
- active psychiatric illness or substance misuse
- concurrent malignancies of another type other than non-melanoma skin cancer
- unable to travel for sessions with smoking cessation counsellor and / or outpatient visits from outset
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
Median and 2-year survival rates in confirmed smokers versus non- smokers newly diagnosed with lung cancer.
Time frame: 24 months
6 secondary outcomes
Median survival and 2-year survival rates by smoking status for early (Stage I/II NSCLC) versus those with advanced (Stage III/IV) NSCLC.
Time frame: 24 months
Number of treatment complications in smokers versus non-smokers (frequency surgical wound complications, radiotherapy induced pneumonitis and median total radiation (Gy) dose; frequency and duration of neutropenic sepses
Time frame: 2 years
Point prevalence of smoking at 0, 3, 6 12, 24 months
Time frame: 2 years
Comparison of changes in health related quality of life (EQ5D) in smokers versus non-smokers
Time frame: 2 years
Accrual and attendance rates of lung cancer patients attending a hospital smoking cessation service
Time frame: 2 years
Estimate of cost per quality adjusted life year gained by smoking cessation advice in both quit strategies for smokers
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Results publication: PubMed 30797485Gemine RE, Ghosal R, Collier G, Parry D, Campbell I, Davies G, Davies K, Lewis KE; LungCast Investigators. Longitudinal study to assess impact of smoking at diagnosis and quitting on 1-year survival for people with non-small cell lung cancer. Lung Cancer. 2019 Mar;129:1-7. doi: 10.1016/j.lungcan.2018.12.028. Epub 2018 Dec 28.
- Derived from this study: PubMed 42480249Gemine RE, Davies GR, Lewis KE; LungCAST Investigators. Quitting Smoking and Two-Year Survival After a Diagnosis of Small-Cell Lung Cancer. Clin Lung Cancer. 2026 Jun 27;27(7):18-23. doi: 10.1016/j.cllc.2026.06.006. Online ahead of print.
- Derived from this study: PubMed 37820539Gemine RE, Davies GR, Lanyon K, Rees SE, Campbell I, Lewis KE; LungCAST Investigators. Quitting smoking improves two-year survival after a diagnosis of non-small cell lung cancer. Lung Cancer. 2023 Dec;186:107388. doi: 10.1016/j.lungcan.2023.107388. Epub 2023 Oct 1.
- Derived from this study: PubMed 37059391Jones M, Lowin J, Sewell B, Gemine RE, Rees SE, Lanyon K, Lewis KE. The Economic Potential of Smoking Cessation Interventions at the Point of Diagnosis of Non-Small Cell Lung Cancer. Value Health. 2023 Aug;26(8):1192-1200. doi: 10.1016/j.jval.2023.03.2429. Epub 2023 Apr 12.
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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.
Keir E Lewis, MD principal investigator
Hywel Dda
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Dr Keir Lewis at 2 sites 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 1 inclusion and 7 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: finished, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median and 2-year survival rates in confirmed smokers versus non- smokers newly diagnosed with lung cancer. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01192256, which also lists 4 linked publications.
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 4 Aug 2022.