Renal Cell Carcinoma (Kidney Cancer)TACTICAL1NCT07171190
Targeted Abdominal CT in Conjunction With Lung Cancer Screening
A study testing Lung Cancer Screening Invitation Intervention and Abdominal scan intervention in people with Renal Cell Carcinoma (Kidney Cancer) and Kidney Cancers, run by University of Cambridge at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Cell Carcinoma (Kidney Cancer), Kidney Cancers, AAA - Abdominal Aortic Aneurysm
- What is being tested?
- Lung Cancer Screening Invitation Intervention and Abdominal scan intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,272 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Nov 2025to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- None
- 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:
Show all 22Show fewer
- 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
- 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).
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jessica Kitt contact
United Kingdom1 site, 1 recruiting
- Recruiting
Hull Teaching Hospitals Trust
Hull, HU3 2JZ
Oliver Byass, 01482 461 616, oliver.byass@nhs.net
About this study
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.
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.
Read more
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
- Being tested
- Lung Cancer Screening Invitation Intervention, Abdominal scan intervention
- Keywords
- Screening, NHS Lung Cancer Screening, Kidney cancer, Abdominal cancer, Lung cancer, Abdominal Aortic Aneurysms (AAA), Abdominal screening
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms, Aortic Aneurysm, Abdominal, Nephrolithiasis, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung Cancer Screening Invitation InterventionOther
Participants are invited to the NHS Lung Cancer Screening to assess lung cancer risk via letter or text message
Abdominal scan interventionDiagnostic test
Receiving an abdominal CT scan at the same time as the lung scan.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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. Receives: 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. Receives: Diagnostic Test: Abdominal scan intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: Up to 6 months after invitation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start11 Nov 2025
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell Carcinoma (Kidney Cancer)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 6,272 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- Collaborators
- Hull University Teaching Hospitals NHS Trust
- Responsible party
- Principal investigator, Grant Stewart, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07171190
- Sponsor's protocol ID
- G128732
- Acronym
- TACTICAL1
- Status last verified
- Dec 2025
- First submitted
- 14 Aug 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07171190
- Acronym / sponsor ID
- TACTICAL1 / G128732
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6,272 participants (estimated)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Collaborators
- Hull University Teaching Hospitals NHS Trust
- Study start
- 11 Nov 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 12 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Invitation control arm | Active comparator | Other: Lung Cancer Screening Invitation InterventionInvited to NHS Lung Cancer Screening to assess lung cancer risk via letter or text message, following the normal process |
| Invitation intervention arm | Experimental | Other: Lung Cancer Screening Invitation InterventionWill 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. |
| Scan control arm | Active comparator | Diagnostic Test: Abdominal scan interventionFor 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. |
| Scan intervention arm | Experimental | Diagnostic Test: Abdominal scan interventionThose 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. |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (22 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung Cancer Screening Invitation InterventionParticipants are invited to the NHS Lung Cancer Screening to assess lung cancer risk via letter or text message | Other | Invitation control arm, Invitation intervention arm |
| Abdominal scan interventionReceiving an abdominal CT scan at the same time as the lung scan. | Diagnostic test | Scan control arm, Scan intervention arm |
Primary outcome
Attendance rate at the LCS phone call
Time frame: 12 weeks after invitation letter is sent
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.
Cluster randomisation assessment
Time frame: At the point of LCS assessment, within 12 weeks of invitation
Successful cluster randomisation of participants into scan control and scan intervention groups as demonstrated by groups of similar size.
Impact of abdominal scan on throughput
Time frame: Up to 6 months after invitation
Average number of participants scanned per standard LCS scanning day is no different when adding the ANCCT
Perceived impact of abdominal scan on throughput
Time frame: Up to 6 months after invitation
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
Incremental time taken for each TACTICAL1 task compared with the existing LCS processes.
Time frame: Up to 6 months after invitation
The observed incremental time taken for each TACTICAL1 task compared with the existing LCS processes for a sub-sample of participants.
Over 75% of participants receiving abdominal scan are satisfied or very satisfied with their scanning unit experience
Time frame: Up to 6 months after invitation
Over 75% of participants are satisfied or very satisfied with their scanning unit experience as demonstrated by a post-scan feedback questionnaire.
1 secondary outcome
Percentage of participants taking up offer of abdominal scan
Time frame: Up to 6 months after invitation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Renal Cell Carcinoma (Kidney Cancer)
RecruitingObservational study
Genetic Analysis of Birt Hogg-Dube Syndrome and Characterization of Predisposition to Kidney Cancer
Kidney Neoplasms, Kidney Cancer
Active, not recruitingPhase 1/2
Study of ST-1898 in Advanced Renal Cell Carcinoma
Advanced Renal Cell Carcinoma
Active, not recruitingPhase 1/2
Pazopanib Hydrochloride and Bevacizumab in Treating Patients With Previously Untreated Metastatic Kidney Cancer
Clear Cell Renal Cell Carcinoma, Stage IV Renal Cell Cancer
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
RecruitingObservational study
Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease
Malignant Neoplasms, Hereditary Neoplastic Syndromes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jessica Kitt contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung Cancer Screening Invitation Intervention and Abdominal scan intervention in people with Renal Cell Carcinoma (Kidney Cancer) and Kidney Cancers, run by University of Cambridge at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Grant Stewart (01223 331199, gds35@cam.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attendance rate at the LCS phone call (time frame: 12 weeks after invitation letter is sent). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.