ClinicalTrials.gg
RecruitingNCT07171190TACTICAL1Updated Dec 19, 2025

Targeted Abdominal CT in Conjunction With Lung Cancer Screening

An interventional study of Lung Cancer Screening Invitation Intervention and Abdominal scan intervention in Renal Cell Carcinoma (Kidney Cancer), Kidney Cancers and AAA - Abdominal Aortic Aneurysm, sponsored by University of Cambridge. Recruiting at 1 site in United Kingdom. Open to participants aged 55 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-19.

Sponsored by University of Cambridge · Not applicable, Interventional, and Screening

From the registry’s dates

  • Started Nov 2025; still recruiting 1 year later.

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Phase
Not applicable
Study type
Interventional
Enrollment
6,272
Allocation
Randomized
Ages
55 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 168 studies in Carcinoma, Renal Cell with a site in United Kingdom — 13 open to participants now, 30 under way, 13 of them phase 3. Carcinoma, Renal Cell · United Kingdom.

Planned enrollment
Largest of 148
6,272 · median 189
Started
2025
with 2 others
No phase
8 of 168
2 open now
Primary completion
2027-10
later than 21 of 29 live
Registered
164th of 168
by date

Among the 168 studies in Carcinoma, Renal Cell with a site in United Kingdom, this one has the largest planned enrollment of the 148 interventional ones that give a count, is one of 3 that started in 2025, is one of 8 with no phase, reaches primary completion later than 21 of the 29 other live ones, and was the 164th registered.

Carcinoma, Renal Cell

2,038 studies on the registry are indexed under Carcinoma, Renal Cell; 395 are open to participants now.

Browse Carcinoma, Renal Cell studies →

Open to participants now

13 of the 168 studies in Carcinoma, Renal Cell with a site in United Kingdom are open now. Recruiting first, the newest first:

7 more — sign in →

All 13 open studies →

A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →

Who these studies take

Of the 307 Carcinoma, Renal Cell studies recruiting now, 254 (83%) set no upper age limit and 18 (6%) stop at 75 or younger; 20 take children under 18; 19 take healthy volunteers.

This study: 55 Years to 70 Years · all sexes · healthy volunteers too.

The full table on the hub →

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02

Study 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.

03

Conditions studied

  • 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
04

Who can participate

Ages eligible
55 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

  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 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 .
    • 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.

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
6,272 participants (estimated)

Study arms

  • 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

    Other: Lung Cancer Screening Invitation Intervention

  • 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.

    Other: Lung Cancer Screening Invitation Intervention

  • 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.

    Diagnostic Test: Abdominal scan intervention

  • 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.

    Diagnostic Test: Abdominal scan intervention

Interventions

  • OtherLung Cancer Screening Invitation Intervention

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

  • Diagnostic testAbdominal scan intervention

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 weeks after invitation letter is sent

  2. Cluster randomisation assessment

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

    Time frame: At the point of LCS assessment, within 12 weeks of invitation

  3. Impact of abdominal scan on throughput

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

    Time frame: Up to 6 months after invitation

  4. 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

    Time frame: Up to 6 months after invitation

  5. 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.

    Time frame: Up to 6 months after invitation

  6. 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.

    Time frame: Up to 6 months after invitation

Secondary outcomes

  1. Percentage of participants taking up offer of abdominal scan

    At least 80% of participants offered the ANCCT, accept the invitation and attend the scan

    Time frame: Up to 6 months after invitation.

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2025 (actual). Primary completion is estimated for Oct 2027, 23 months after the start.

Of 119 non-industry interventional studies with no phase under Carcinoma, Renal Cell, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 114. This study's planned 23 months is below that.

Counting every sponsor, half of 126 studies reached it within 45 months; a quarter within 22 and three quarters within 114.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 14, 2025
First posted
Sep 12, 2025
StartActual
Nov 11, 2025
Primary completionEst.
Oct 2027
CompletionEst.
Oct 2027
Last update
Dec 19, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07171190
Collaborators
Hull University Teaching Hospitals NHS Trust
Responsible party
Grant Stewart (Professor Grant Stewart, University of Cambridge) — Principal investigator
First posted
Sep 12, 2025
Start date
Nov 11, 2025
Primary completion
Oct 2027 (estimated)
Completion
Oct 2027 (estimated)
Last update
Dec 19, 2025

Study contacts

Grant Stewart
Contact
gds35@cam.ac.uk
01223 331199
Jessica Kitt
Contact
jk896@cam.ac.uk

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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