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 or with elevated sugar levels within the last 200 days.
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)
Confirmed type 2 DM diagnosis established within the last 200 days or an initial elevated HbA1c ≥ 48 mmol/mol or 6.5% obtained within the last 200 days. This includes people who have a first elevated HbA1c (≥ 48 mmol/mol or 6.5%) within the last 200 days, even if subsequent HbAc1 measurements return to the the normal range.
Willing to provide up to 30 mL of blood for each study visit
Willing and eligible to undergo MRI or CT scan
Disqualifiers
Prior type I or type II DM diagnosis or an initial HbA1c ≥ 48 mmol/mol or 6.5% obtained prior to the 200-day inclusion window, except gestational elevated HbA1c.
A history of pancreatic cancer, pancreatic neuroendocrine tumour (pNET) or Pancreatitis
Under investigation for or confirmed pancreatic cancer
Under investigation/surveillance for pancreatic cyst
Trial design
Design model
Single group
Treatments tested in this trial
Avantect Pancreatic Cancer Test
DeviceAvantect test
Treatment groups
5,000 Participants
are divided into 1 treatment groupGroup A: InterventionalExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Sensitivity of the Avantect test
The proportion of individuals with one or more Avantect "detected" test result who have pancreatic cancer diagnosed via imaging in relation to all individuals in the study who had pancreatic cancer diagnosed.
Time frame
The final analysis will be carried out after 3-year follow up data has been collected for all 5,000 participants.2
Specificity of the Avantect test
The proportion of individuals 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 study who did not have a pancreatic cancer diagnosis.
Time frame
The final analysis will be carried out after 3-year follow-up data has been collected for all 5,000 participants.Secondary outcomes
1
Stage shift
The proportion of pancreatic cancers cases diagnosed at stage I/II out of all participants diagnosed with pancreatic cancer between SAFE-D participants and point-estimate of the proportion from comparative data. Stage shift will be considered successful if the lower-bound of the 95% one-sided proportion in SAFE-D participants is higher than the proportion from comparative data.
Time frame
The analysis will be carried out after 3-year follow-up data has been collected for all 5,000 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 with a sample size of 5,000, pancreatic cancer prevalence of 0.8%, and 5% lost from the per protocol population. There will be an expected 261 individuals with an Avantect "detected" result. 9.6% (25/261) 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
The final analysis will be carried out after 3-year follow-up data has been collected for all 5,000 participants.3
Negative Predictive Value (NPV) of Avantect test in ruling out pancreatic cancer (PC)
With a sample size of 5,000, PC prevalence of 0.8%, and 5% lost from the per protocol population, there will be an expected 4,489 individuals without an Avantect "detected" result. 99.6% (4,476/4,489) 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
The analysis will be carried out after 3-year follow-up data has been collected for all 5,000 participants.4
Resection rate of pancreatic cancer
Percentage of participants with pancreatic cancer who underwent resection. The analysis will be conducted by comparing the proportion of pancreati cancer cases that underwent resection as a treatment modality between SAFE-D participants and the point-estimate of the proportion from comparative data. Resection rate will be considered successful if the lower-bound of the 95% one-sided proportion in SAFE-D participants is higher than the proportion from comparative data.
Time frame
The analysis will be carried out after 3-year follow-up data has been collected for all 5,000 participants.Other outcomes
1
Time-to-event outcomes
To estimate the time from new onset diabetes diagnosis to pancreatic cancer diagnosis.
Time frame
The analysis will be carried out after 3-year follow-up data has been collected for all 5,000 participants.2
Overall survival
To estimate the overall survival of study participants.
Time frame
The analysis will be carried out after 3-year follow-up data has been collected for all 5,000 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.
Time frame
The analysis will be carried out after 3-year follow-up data has been collected for all 5,000 participants.4
High-grade neoplasia
To investigate the performance characteristics for high-grade neoplasia.
Time frame
The analysis will be carried out after 3-year follow-up data has been collected for all 5,000 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