PDAC - Pancreatic Ductal AdenocarcinomaASSURENCT07805681
Observational Registry Evaluating the Clinical Impact of the Blood-Based Biomarker Test for Early-Stage Pancreatic Ductal Adenocarcinoma
An observational study of PDAC - Pancreatic Ductal Adenocarcinoma and Pancreatic Cancer Stage I, run by Immunovia, Inc..
Trial summary
The goal of this observational registry is to examine the changes made to pancreatic cancer surveillance management following the real-world clinical use of PancreaSure testing among individuals at increased risk for pancreatic ductal adenocarcinoma. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- PDAC - Pancreatic Ductal Adenocarcinoma, Pancreatic Cancer Stage I, Pancreatic Cancer Stage II
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Apr 2029
- How long will I take part?
- 2 Years
- Phase
- Observational
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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of adults (>45 years) at elevated risk for PDAC or otherwise identified for PDAC early detection testing by their clinician. Factors for high risk include: * Family history in ≥ 2 first-degree relatives, or * Known pathogenic germline mutation (BRCA1/2, CDKN2A, PALB2, ATM, STK11, PRSS1), or * Pancreatic cystic lesion, or * New-onset diabetes with additional risk factors, or * Clinician discretion
Who may be able to join
- Able to provide informed written consent and complete the survey in English or Spanish
- >45 years of age
- PancreaSure ordered as part of routine clinical care.
- At elevated risk for PDAC or is deemed appropriate for PDAC early detection testing based on:
- Family history in ≥ 2 first-degree relatives, or
- Known pathogenic germline mutation (BRCA1/2, CDKN2A, PALB2, ATM, STK11, PRSS1), or
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- Pancreatic cystic lesion, or
- New-onset diabetes with additional risk factors, or
- Clinician discretion
Who cannot join
- Prior diagnosis of PDAC or other active malignancy within 3 years (except non-melanoma skin cancer).
- Participation in interventional investigational studies that may bias test use.
- Inability or unwillingness to comply with follow-up schedule.
About this study
Official title: A Multicenter Observational Registry Evaluating the Clinical Impact of the Blood-Based Biomarker Test, PancreaSure, for Early-Stage Pancreatic Ductal Adenocarcinoma (PDAC) Detection in High-Risk Surveillance Program
The goal of this observational registry is to examine the changes made to pancreatic cancer surveillance management following the real-world clinical use of PancreaSure testing among individuals at increased risk for pancreatic ductal adenocarcinoma. The main question it aims to answer is, does surveillance management and intent change following the return of PancreaSure binary results.
Read the detailed description
This observational registry designed to evaluate the impact of PancreaSure, a blood-based biomarker test, on the management of pancreatic cancer surveillance in individuals at high risk for pancreatic ductal adenocarcinoma. The study aims to understand how the test results influence clinical decisions, such as whether doctors escalate, maintain, or de-escalate surveillance plans for patients. The study will also assess how the test is used in real-world clinical settings, its impact on healthcare utilization, and patient-reported outcomes like anxiety, satisfaction, and understanding of test results.
The study will enroll a minimum of 400 high-risk individuals aged 45 or older who are part of a recognized pancreatic surveillance programs for whom the PancreaSure test is ordered as part of routine clinical care. Participants will be followed for up to 24 months, with key assessments occurring 7-14 days after the test results are returned, and again at 12 and 24 months. The primary objective is to evaluate changes in clinician decision-making regarding surveillance management following receipt of PancreaSure test results, stratified by positive versus negative findings. Secondary objectives include analyzing how often the test is ordered, how it affects follow-up imaging, and how the patients perceive the test's impact on their care. Exploratory objectives will look at the clinical outcomes, such as the stage of cancer at diagnosis and the economic impact of using the test.
The study does not introduce experimental interventions, and all medical decisions remain at the discretion of the treating clinicians.
- Conditions
- PDAC - Pancreatic Ductal Adenocarcinoma, Pancreatic Cancer Stage I, Pancreatic Cancer Stage II, Cancer Diagnosis
- Keywords
- Pancreatic Cancer Diagnosis, Pancreatic Cancer, PDAC, Early Detection, Pancreatic Cancer Stage I, Pancreatic Cancer Stage II, Pancreatic Ductal Adenocarcinoma, Pancreatic Cancer Detection
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| High Risk Individuals | Individuals who are considered at high-risk for developing pancreatic ductal adenocarcinoma. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in documented pancreatic surveillance management planning and intent following return of PancreaSure results, assessed within a predefined post-result window of 7-14 days following tR, relative to the documented pre-test surveillance plan and stra
Measured: 7-14 days following return of results
Secondary outcomes (3)
Describing patterns of PancreaSure test utilization in clinical practice
Measured: 0-12 Months Following Enrollment
Downstream clinical actions and follow-through
Realized care delivery and surveillance procedures will be assessed over a 12-month observation period following test prescription (t0). This will include the number and type of follow-up imaging (MRI, CT, EUS) within 12 months of testing; referral rates to specialty services; completion rate of recommended follow-up imaging; and how realized care compares to the pre-test surveillance plan.
Measured: 0-12 months following enrollment
Patient-reported outcomes
Perceived anxiety, satisfaction, and understanding of results. Barriers to testing
Measured: 0- 12 months following enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PDAC - Pancreatic Ductal AdenocarcinomaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Immunovia, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07805681
- Sponsor's protocol ID
- ASSURE-12
- Acronym
- ASSURE
- Status last verified
- Sep 2026
- First submitted
- 24 Apr 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No