Studies Examining the Importance of Smoking After Being Diagnosed With Lung Cancer (LungCast)
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|ClinicalTrials.gov Identifier: NCT01192256|
Recruitment Status : Recruiting
First Posted : September 1, 2010
Last Update Posted : November 22, 2018
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. Survival, cancer progression and treatment complications will be recorded and compared in smokers, ex-smokers and never smokers.
|Condition or disease|
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 Type :||Observational|
|Estimated Enrollment :||2400 participants|
|Official Title:||Does Smoking Status After Being Diagnosed With Lung Cancer Influence Outcome? An Observational Cohort Study.|
|Actual Study Start Date :||March 2010|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||July 2021|
- Median and 2-year survival rates in confirmed smokers versus non- smokers newly diagnosed with lung cancer. [ Time Frame: 24 months ]
- 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 ]
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): NCT01192256
|Contact: Rachel E Gemine, PhD||+44 email@example.com|
|Contact: Keir Lewis, MD FRCP||+44 firstname.lastname@example.org|
|Llandough Hospital, Cardiff and Vale University Health Board||Recruiting|
|Cardiff, Wales, United Kingdom|
|Contact: Diane Parry, FRCP +44 2920 747747 email@example.com|
|Sub-Investigator: Ian Campbell, FRCP|
|Sub-Investigator: Helen Davies, MRCP|
|Hywel Dda Health Board||Recruiting|
|Llanelli, Wales, United Kingdom, SA14 8QF|
|Contact: Keir E Lewis, MD +44 1554783133 firstname.lastname@example.org|
|Contact: Chris Tattersall, BSc email@example.com|
|Sub-Investigator: Gareth Collier, MRCP|
|Principal Investigator: Rachel Roberts, BSc|
|Principal Investigator:||Keir E Lewis, MD||Hywel Dda|