UK Lung cancer Screening pilot trial (UKLS)

Conditions

Lung cancer Cancer Malignant neoplasm of bronchus and lung

Field JK, Duffy SW, Baldwin DR, Brain KE, Devaraj A, Eisen T, Green BA, Holemans JA, Kavanagh T, Kerr KM, Ledson M, Lifford KJ, McRonald FE, Nair A, Page RD, Parmar MK, Rintoul RC, Screaton N, Wald NJ, Weller D, Whynes DK, Williamson PR, Yadegarfar G, Hansell DM.

2016-05-01194 citations

10.3310/hta20400

Interventions

Every participant attends a recruitment centre where they watch a DVD, go through fully informed consent, undertake a lung function test, and provide a sample of blood, sputum and buccal scrape. They

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Risk criteria based on the LLP Risk Prediction Model (includes age, sex, smoking duration, history of previous pneumonia, history of previous cancer, family history [early/late onset], exposure to asbestos - algorithm) 2. Males and females aged between 50 to 75 years old 3. Fully informed written consent given

Exclusion criteria

Exclusion criteria: 1. Unable to give consent 2. Co-morbidity which would unequivocally contraindicate either screening or treatment if lung cancer were detected 3. A CT scan of the chest performed within one year of the invitation to be screened 4. Any condition precluding written informed consent 5. Inability to lie flat 6. Weight greater than 200 kg (too large for CT scanner)

Design outcomes

Primary

Measure	Time frame
1. Will the proposed method of recruitment (based on the protocol of a two-stage postal survey of risk directly aimed at the general population) deliver the required numbers? This entails estimating: 1.1. Response rates to questionnaires 1.2. Proportion of subjects approached who are eligible 1.3. Proportion of eligible subjects who consent to randomisation 1.4. Proportion of subjects randomised to LDCT who comply with the intervention 2. We shall also monitor the performance of all aspects of the clinical care pathway and the research evaluation technicalities, including for example the database system	—

Measure

Time frame

1. Will the proposed method of recruitment (based on the protocol of a two-stage postal survey of risk directly aimed at the general population) deliver the required numbers? This entails estimating: 1.1. Response rates to questionnaires 1.2. Proportion of subjects approached who are eligible 1.3. Proportion of eligible subjects who consent to randomisation 1.4. Proportion of subjects randomised to LDCT who comply with the intervention 2. We shall also monitor the performance of all aspects of the clinical care pathway and the research evaluation technicalities, including for example the database system

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Secondary

Measure	Time frame
1. How many subjects need to be approached to obtain the required full trial population? 2. Do the recruitment, randomisation and scanning protocols work in practice? Is the recruit?s journey from initial survey to LDCT scanning logistically efficient? 3. Are both fixed and mobile CT units practicable for trial purposes - is one preferable to the other in terms of cost/convenience? 4. Testing of staff training programmes 5. Testing of QA procedures, for radiology and technology, including radiation dose aspects 6. Do questionnaires or consent/information procedures or documentation need revising? 7. Review recruitment in hard-to-reach groups 8. UKLS database capable of capturing all of the required information from the recruitment phase to CT screening, investigations and treatment 11. Collection of blood/sputum specimens at the recruitment phase, and QC 12. Provide screening data for HTA review at month 12 of the pilot for review and decision whether to fund the main UKLS trial 13. Management of the UKLS through the Liverpool Cancer Trials Unit (LCTU)	—

Measure

Time frame

1. How many subjects need to be approached to obtain the required full trial population? 2. Do the recruitment, randomisation and scanning protocols work in practice? Is the recruit?s journey from initial survey to LDCT scanning logistically efficient? 3. Are both fixed and mobile CT units practicable for trial purposes - is one preferable to the other in terms of cost/convenience? 4. Testing of staff training programmes 5. Testing of QA procedures, for radiology and technology, including radiation dose aspects 6. Do questionnaires or consent/information procedures or documentation need revising? 7. Review recruitment in hard-to-reach groups 8. UKLS database capable of capturing all of the required information from the recruitment phase to CT screening, investigations and treatment 11. Collection of blood/sputum specimens at the recruitment phase, and QC 12. Provide screening data for HTA review at month 12 of the pilot for review and decision whether to fund the main UKLS trial 13. Management of the UKLS through the Liverpool Cancer Trials Unit (LCTU)

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Countries

England, United Kingdom

Outcome results

None listed