An Observational Cohort Study Investigating the Impact of Community-based Lung Cancer Screening Across a Deprived Geographical Area and the Role of Biomarkers for the Early Detection of Lung Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 9,730
- 试验地点
- 1
- 主要终点
- Evaluation of biomarkers
研究概览
简要总结
The Manchester Lung Health Study (qUEST) will assess the uptake of a community-based lung cancer screening service and its impact across a deprived area of North and East Manchester, which has high rates of lung cancer. One measure will be to compare the number and stage of lung cancers detected through screening to those detected outside of screening. In addition we will investigate the potential of a blood and nose test to detect lung cancer or to help decide who would benefit from screening. We will also see if these samples can help with the interpretation of CT scans. One of the problems with lung cancer CT screening is that you detect lung nodules in which we are not sure if they are benign or cancerous. Therefore we are also looking to see if a biomarker can help us work out which are cancerous and which are benign.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any individual attending the Manchester Lung Health service who has a lung health check as they meet the service inclusion exclusion criteria (see below):
- •Manchester Lung Health service inclusion criteria:
- •Age 55-80
- •Ever smoker
- •Registered with a GP in the North or East Manchester area
- •Manchester Lung Health service exclusion Criteria:
- •Lung cancer diagnosis within 5 years
- •Listed on a palliative care register
- •Chest CT scan within 3 months
排除标准
- •Unable to give informed consent to study participation.
- •Biomarker sub-study:
- •Inclusion Criteria:
- •Any individual attending the M-LHC service who is eligible and agrees to undergo LDCT screening.
- •Has consented to the main study.
- •Exclusion Criteria:
- •Unable to give informed consent to study participation
- •Decline participation in LDCT lung cancer screening
- •Known blood borne virus e.g. HIV or Hepatitis B, C
结局指标
主要结局
Evaluation of biomarkers
时间窗: Over 3 years to determine long term outcomes from screening
Sensitivity and specificity of a biomarker or panel of biomarkers to detect early stage lung cancer.
Uptake of the Manchester lung health check service
时间窗: Over 3 years to determine long term outcomes from screening
The overall uptake will be assessed and analysed according to age, sex, smoking status, ethnicity and socio economic status.
次要结局
- Screening adherence(Over 3 years to determine long term outcomes from screening)
- Treatment for lung cancer related to screening service(Over 3 years to determine long term outcomes from screening)
- False positive rates(Over 3 years to determine long term outcomes from screening)
- Recall rates(Over 3 years to determine long term outcomes from screening)
- Investigations generated from screening(Over 3 years to determine long term outcomes from screening)
- Adverse events generated from screening(Over 3 years to determine long term outcomes from screening)
- Smoking prevalence(Over 3 years to determine long term outcomes from screening)
- Comparison between cohort and those residents diagnosed in north and east manchester(Over 3 years to determine long term outcomes from screening)
- Evaluation of screening numbers required to detect lung cancer(Over 3 years to determine long term outcomes from screening)
- False negative rates(Over 3 years to determine long term outcomes from screening)
- Coronary artery calcification(Over 3 years to determine long term outcomes from screening)
- Histological subtype for lung cancer related to screening service(Over 3 years to determine long term outcomes from screening)
- Interval cancers(Over 3 years to determine long term outcomes from screening)
- Resection rates generated from screening(Over 3 years to determine long term outcomes from screening)
- Assessment of the British Thoracic Society pulmonary nodule guidelines(Over 3 years to determine long term outcomes from screening)
- Diagnosis route for lung cancer related to screening service(Over 3 years to determine long term outcomes from screening)
- Rates of investigation of benign disease(Over 3 years to determine long term outcomes from screening)
- Benign resection rate in participants(Over 3 years to determine long term outcomes from screening)
- Undiagnosed airflow obstruction(Over 3 years to determine long term outcomes from screening)