Surveillance of Pancreatic Health After Diabetes Diagnosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-84
SponsorUniversity Hospital Southampton NHS Foundation Trust
About this trial
The goal of this interventional study is to evaluate if the novel diagnostic blood test, called Avantect can early detect pancreatic cancer in patients diagnosed with type 2 diabetes within the last 6 months.
Participants will:
* attend 3 study visits over 12 months time * provide a blood sample at each study visit * complete an anxiety questionnaire at each visit.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
50 - 84 years of age at the time of enrolment (within year of birth, not month of birth)
Haemoglobin A1c (HbA1c) ≥ 48 or 6.5% and/or confirmed type II DM diagnosed within the last 180 days (+20 days flexibility allowance)
Willing to provide up to 30 mL of blood for each study visit
Willing and eligible to undergo MRI scan (or CT scan if MRI is contraindicated)
Disqualifiers
Prior type I or type II DM diagnosis > 6 months
A history of pancreatic cancer, pancreatic neuroendocrine tumour (pNET) or Pancreatitis
Under investigation for pancreatic cancer / pancreatic cyst
Any known pancreatic surgery (not including ERCP), or other major surgery requiring anaesthesia within 3 months
Trial design
Design model
Parallel
Treatments tested in this trial
Avantect Pancreatic Cancer Test
DeviceAvantect test
Treatment groups
15,000 Participants
are divided into 2 treatment groupsGroup A: Intervention ArmExperimental treatment 1 intervention
Group B: Control Arm (Standard of Care [SoC] arm)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Sensitivity of the Avantect test
The proportion of participants in the intervention arm with one (or more) Avantect "detected" test result who have pancreatic cancer diagnosed via imging in relation to all individuals in the intervention arm who had pancreatic cancer diagnosed.
Time frame
Stage 1 analysis will be carried out 6 months after the T1 visit for 3,200 participants in the intervention arm. Stage 2 analysis will be carried out after 3-year follow-up data has been collected for all 15,000 participants.2
Specificity of the Avantect test
The proportion of participants in the intervention arm with one or more Avantect "not detected" test results, and no Avantect "detected" results, who did not have a pancreatic cancer diagnosis in relation to all individuals in the intervention arm who did not have a pancreatic cancer diagnosis.
Time frame
Stage 1 analysis will be carried out 6 months after the T1 visit for 3,200 participants in the intervention arm. Stage 2 analysis will be carried out after 3-year follow-up data has been collected for all 15,000 participants.3
Resectability rate of pancreatic cancer
The proportion of pancreatic cancers deemed resectable by the study MDT divided by the number of pancreatic cancers and will be compared between arms.
Time frame
Stage 1 analysis will be carried out 6 months after the T1 visit for 3,200 participants in the intervention arm. Stage 2 analysis will be carried out after 3-year follow-up data has been collected for all 15,000 participants.Secondary outcomes
1
Stage shift
The proportion of pancreatic cancers cases diagnosed at stage I/II vs III/IV between the intervention and control arms. A proportion of 60% (44/73 PCs) is expected in the intervention arm versus 35% (26/73 PCs) in the control arm, which provides 90% power at a one-sided alpha of 0.05. Stage shift will be considered successful if the proportion in the intervention arm is higher than the rate in the control arm at a one-sided p-value of 0.05.
Time frame
Stage 1 analysis will be carried out 6 months after the T1 visit for 3,200 participants in the intervention arm. Stage 2 analysis will be carried out after 3-year follow-up data has been collected for all 15,000 participants.2
Positive Predictive Value (PPV) of Avantect test in detecting pancreatic cancer (PC)
Percentage of participants with an Avantect "detected" result who have pancreatic cancer diagnosed. The analysis will be conducted within the intervention arm. With a sample size of 7,500, PC prevalence of 1%, and 2.5% lost from the per protocol population, there will be an expected 410 individuals with an Avantect "detected - abnormal" result. 11.6% (48/410) are expected to have a PC. PPV will be considered successful if a null PPV of 5% can be ruled out at a one-sided p-value of 0.05.
Time frame
Stage 1 analysis will be carried out 6 months after the T1 visit for 3,200 participants in the intervention arm. Stage 2 analysis will be carried out after 3-year follow-up data has been collected for all 15,000 participants.3
Negative Predictive Value (NPV) of Avantect test in ruling out pancreatic cancer (PC)
Percentage of participants with no Avantect "detected" test result who have no diagnosis of pancreatic cancer. The analysis will be conducted within the intervention arm with a sample size of 7,500, PC prevalence of 1%, and 2.5% lost from the per protocol population, will be an expected 6,902 individuals without an Avantect "detected - abnormal" result. 99.6% (6,877/6,902) are expected to not have a diagnosis of PC. NPV will be considered successful if a null NPV of 99% can be ruled out at a one-sided p-value of 0.05.
Time frame
Stage 1 analysis will be carried out 6 months after the T1 visit for 3,200 participants in the intervention arm. Stage 2 analysis will be carried out after 3-year follow-up data has been collected for all 15,000 participants.4
Resection rate of pancreatic cancer
Percentage of participants with pancreatic cancer who underwent resection. The analysis will be conducted by comparing resection between the intervention and control arms. With a sample size of 15,000, PC prevalence of 1%, and 2.5% lost to follow-up, there will be an expected 73 cases of PC in each arm. It is assumed that 5% of those deemed resectable will not undergo resection, for an expected rate of 38% (28/73) in the Intervention arm versus 13% (9/73) in the control arm. Resection rate will be considered successful if the proportion in the intervention arm is higher than the rate in the control arm at a one-sided p-value of 0.05.
Time frame
Stage 1 analysis will be carried out 6 months after the T1 visit for 3,200 participants in the intervention arm. Stage 2 analysis will be carried out after 3-year follow-up data has been collected for all 15,000 participants.Other outcomes
1
Time-to-event outcomes
To estimate the time from new onset diabetes diagnosis to pancreatic cancer diagnosis. This will be analysed within intervention arm.
Time frame
Stage 1 analysis will be carried out 6 months after the T1 visit for 3,200 participants in the intervention arm. Stage 2 analysis will be carried out after 3-year follow-up data has been collected for all 15,000 participants.2
Overall survival
To estimate the overall survival of study participants. This will be compared between intervention and control arm.
Time frame
Stage 1 analysis will be carried out 6 months after the T1 visit for 3,200 participants in the intervention arm. Stage 2 analysis will be carried out after 3-year follow-up data has been collected for all 15,000 participants.3
Effect of the Avantect test on state anxiety over time
To assess the effect of the Avantect test on state anxiety over time. This will be compared between intervention and control arm.
Time frame
Stage 1 analysis will be carried out 6 months after the T1 visit for 3,200 participants in the intervention arm. Stage 2 analysis will be carried out after 3-year follow-up data has been collected for all 15,000 participants.4
High-grade neoplasia
To investigate the performance characteristics for high-grade neoplasia. This will be analysed within intervention arm.
Time frame
Stage 1 analysis will be carried out 6 months after the T1 visit for 3,200 participants in the intervention arm. Stage 2 analysis will be carried out after 3-year follow-up data has been collected for all 15,000 participants.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital Southampton NHS Foundation Trust
Lead sponsor
ClearNote Health
Collaborator
Source ClinicalTrials.gov