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RECRUITING

NCT07171190

Targeted Abdominal CT in Conjunction With Lung Cancer Screening

Sponsor: University of Cambridge

View on ClinicalTrials.gov

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.

Official title: 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.

Key Details

Gender

All

Age Range

55 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

6272

Start Date

2025-11-11

Completion Date

2027-10

Last Updated

2025-12-19

Healthy Volunteers

Yes

Conditions

Renal Cell Carcinoma (Kidney Cancer)Kidney Cancers AAA - Abdominal Aortic Aneurysm Renal Stones

Interventions

OTHER

Lung Cancer Screening Invitation Intervention

Participants are invited to the NHS Lung Cancer Screening to assess lung cancer risk via letter or text message

DIAGNOSTIC_TEST

Abdominal scan intervention

Receiving an abdominal CT scan at the same time as the lung scan.

1. For the individual level randomisation to invitation control or invitation intervention Inclusion criteria: To be randomised at the individual level to receive an invitation letter for LCS (standard of care; invitation control) versus invitation letter for LCS with potential for an additional abdominal scan (invitation intervention): * 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. Exclusion criteria • None 2. Eligibility criteria for the cluster level randomisation to scan intervention or scan control Inclusion criteria a): To be eligible for the cluster level randomisation the participant must: * Have been individually randomised to the invitation intervention arm * Have booked in for a LCS assessment Inclusion criteria b): To receive the CT Thorax plus ANCCT, the participant must: * 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 Exclusion criteria Existing LCS exclusion criteria: * Participant does not have capacity to give consent (standard criteria for assessing capacity apply). * Weight or physical size exceeds restrictions for scanner (\>200kg). * Participant unable to lie flat. * Poor physical fitness such that treatment with curative intent would be contra-indicated. * Participants who have had a full CT Thorax that meets the image reconstruction parameters of the programme in the last 12 months are not excluded from the lung screening programme, but would have their CT Thorax appointment deferred until 12 months have elapsed since that last scan, provided they still meet all inclusion criteria and have no exclusion criteria - if the deferred appointment is within the timeframe for TACTICAL1, they remain eligible but if deferred appointment is outside the timeframe for TACTICAL1 they would not be eligible. Additional TACTICAL1 exclusion criteria: • Had an abdominal CT in the previous 12 months or has one booked within the next 3 months. * For HNY, this is checked before the LCS assessment. Therefore, participants will be excluded before the LCS assessment. * For WYH, this is only checked after the LCS assessment. Therefore, anyone having had an abdominal CT in the previous 12 months or with one booked within the next 3 months will be excluded at this point (see 8.6). 3. Eligibility criteria for the process evaluation Health care professionals: Healthcare professionals involved in the delivery of LCS in any of the study areas who agree to take part. Participants: People individually randomised to the invitation intervention arm who attend the LCS assessment or the scanning unit within the study period and who agree to be interviewed.

Locations (1)

Hull Teaching Hospitals Trust

Hull, United Kingdom