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Targeted Abdominal CT in Conjunction With Lung Cancer Screening - a Pilot Study (TACTICAL1): a Randomised Controlled Pilot Study of Adding Abdominal Non-contrast CT to Lung Cancer Screening CT Thorax Amongst High Lung Cancer Risk Ever-smokers Aged 55-70.

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Early detection through screening can improve cancer survival by identifying it when it's most treatable. The NHS now offers Lung Cancer Screening (LCS) assessments to people aged 55-74 who have ever smoked. Those at higher risk of lung cancer are offered a lung scan. This group also has a high risk of developing abdominal cancers, such as kidney cancer. A recent study explored whether it would be feasible to extend the lung scan to include the abdomen. Results showed most participants supported this addition, and the number of serious findings was similar to those detected in UK breast or bowel cancer screening programmes. However, the abdominal scan was only offered on the day of the lung scan, giving little time for people to consider their decision. The process also added too much time to be practical for widespread implementation. This new study will: * Test whether mentioning the possible abdominal scan in the initial LCS invitation affects participation in LCS assessments. * Test new processes to assess if the abdominal scan can be added to the lung scan with minimal extra time. * Check if participants can be split between the lung scan only group and lung and abdominal scan group using an approach called 'cluster randomisation'. This will be important in case a bigger trial is needed. * See whether the additional processes are acceptable People aged 55-70 who are invited to the lung cancer screening will be eligible to take part in this study. Only those who are found to be at a high risk of lung cancer after their assessment, and therefore offered a lung scan, will be offered the abdominal scan, provided they have not had an abdominal scan in the previous 12 months or one booked in the next 3 months. This study will take place in two existing lung cancer screening locations in Yorkshire.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 70
Healthy Volunteers: t
View:

• Be eligible to be invited to the first round of a West Yorkshire and Harrogate LCS or a Humber and North Yorkshire Cancer Alliance LCS (i.e. have been identified as a smoker or ex-smoker and registered as living within the relevant LCS catchment area).

• Be registered with a GP in England.

• Be aged 55-70 years 364 days old at the date of invitation.

• Have been individually randomised to the invitation intervention arm

• Have booked in for a LCS assessment

• Have been randomised to the scan intervention cluster

• Be invited to attend for a LDCT Thorax based upon scores on either PLCOM2012 or Liverpool Lung Project (LLP) risk prediction models (PLCOM2012 risk of ≥1.51% over six years or LLPver2 five-year risk of ≥2.5%)14 during the LCS assessment.

• Have attended the lung scan appointment

• Have given electronic or written informed consent to participate

Locations
Other Locations
United Kingdom
Hull Teaching Hospitals Trust
RECRUITING
Hull
Contact Information
Primary
Grant Stewart
gds35@cam.ac.uk
01223 331199
Backup
Jessica Kitt
jk896@cam.ac.uk
Time Frame
Start Date: 2025-11-11
Estimated Completion Date: 2027-10
Participants
Target number of participants: 6272
Treatments
Active_comparator: Invitation control arm
Invited to NHS Lung Cancer Screening to assess lung cancer risk via letter or text message, following the normal process
Experimental: Invitation intervention arm
Will have additional text included in the standard Lung Cancer Screening letter or text explaining that, if eligible, they may also be offered a scan of their abdomen at the same time as their lungs.
Active_comparator: Scan control arm
For the scan control batches, those who are 'high risk' following the LCS assessment will have an appointment booked for LCS in the normal way by the LCS assessor.
Experimental: Scan intervention arm
Those who are 'high risk' following the LCS assessment will be invited to have an abdominal CT scan at the same time as their lung scan.
Sponsors
Collaborators: Hull University Teaching Hospitals NHS Trust
Leads: University of Cambridge

This content was sourced from clinicaltrials.gov