Targeted Abdominal CT in Conjunction With Lung Cancer Screening

NCT07171190 | Recruiting

• 1 other identifier: G128732
• Study Type: interventional
• Target: 6,272
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Screening; NHS Lung Cancer Screening; Kidney cancer; Abdominal cancer; Lung cancer; Abdominal Aortic Aneurysms (AAA); Abdominal screening

Outcome Measures

Primary Outcomes (6)

• Attendance rate at the LCS phone call

  Attendance rate of the invitation intervention group to the LCS phone call is non-inferior to the attendance rate of the invitation control group and if so, whether it is superior.

  12 weeks after invitation letter is sent

• Cluster randomisation assessment

  Successful cluster randomisation of participants into scan control and scan intervention groups as demonstrated by groups of similar size.

  At the point of LCS assessment, within 12 weeks of invitation

• Impact of abdominal scan on throughput

  Average number of participants scanned per standard LCS scanning day is no different when adding the ANCCT

  Up to 6 months after invitation

• Perceived impact of abdominal scan on throughput

  Data from daily short questionnaire completed by scanning unit staff shows perceived impact of TACTICAL activities on normal LCS processes is no different when ANCCT is added for at least 80% of days

  Up to 6 months after invitation

• Incremental time taken for each TACTICAL1 task compared with the existing LCS processes.

  The observed incremental time taken for each TACTICAL1 task compared with the existing LCS processes for a sub-sample of participants.

  Up to 6 months after invitation

• Over 75% of participants receiving abdominal scan are satisfied or very satisfied with their scanning unit experience

  Over 75% of participants are satisfied or very satisfied with their scanning unit experience as demonstrated by a post-scan feedback questionnaire.

  Up to 6 months after invitation

Secondary Outcomes (1)

• Percentage of participants taking up offer of abdominal scan

  Up to 6 months after invitation.

Study Arms (4)

Invitation control arm

ACTIVE COMPARATOR

Invited to NHS Lung Cancer Screening to assess lung cancer risk via letter or text message, following the normal process

Other: Lung Cancer Screening Invitation Intervention

Invitation intervention arm

EXPERIMENTAL

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.

Other: Lung Cancer Screening Invitation Intervention

Scan control arm

ACTIVE COMPARATOR

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.

Diagnostic Test: Abdominal scan intervention

Scan intervention arm

EXPERIMENTAL

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.

Diagnostic Test: Abdominal scan intervention

Interventions

Abdominal scan intervention DIAGNOSTIC_TEST

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

Scan control arm; Scan intervention arm

Lung Cancer Screening Invitation Intervention OTHER

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

Invitation control arm; Invitation intervention arm

Eligibility Criteria

• Age: 55 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• None
• Eligibility criteria for the cluster level randomisation to scan intervention or scan control
• 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
• 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.
• 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).

Sponsors & Collaborators

• University of Cambridge: lead
• Hull University Teaching Hospitals NHS Trust: collaborator

Study Sites (1)

Hull Teaching Hospitals Trust

Hull, HU3 2JZ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell; Kidney Neoplasms; Aortic Aneurysm, Abdominal; Nephrolithiasis; Lung Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Urolithiasis; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Grant Stewart

CONTACT

01223 331199; gds35@cam.ac.uk

Jessica Kitt

CONTACT

jk896@cam.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Grant Stewart

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: September 12, 2025
• Study Start: November 11, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)