Targeted Abdominal CT in Conjunction With Lung Cancer Screening

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-70
SponsorUniversity of Cambridge

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

For the individual level randomisation to invitation control or 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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lung Cancer Screening Invitation Intervention

    Other intervention

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

  • Abdominal scan intervention

    Diagnostic test

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

Treatment groups

6,272 Participants
are divided into 4 treatment groups
Group A: Invitation control armActive comparator 1 intervention
Group B: Invitation intervention armExperimental treatment 1 intervention
Group C: Scan control armActive comparator 1 intervention
Group D: Scan intervention armExperimental treatment 1 intervention

Trial outcomes

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

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Cambridge

Lead sponsor

Hull University Teaching Hospitals NHS Trust

Collaborator