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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..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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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
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
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 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
Show all 9Show fewer
  • 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.

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 groups in NCT07805681
Study groupRoleWhat they receive
High Risk IndividualsIndividuals 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.

  1. 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)

  1. Describing patterns of PancreaSure test utilization in clinical practice

    Measured: 0-12 Months Following Enrollment

  2. 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

  3. 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.

  1. First posted4 Sep 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionJan 2028 (estimated)
  4. Study completionApr 2029 (estimated)

Resources

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
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

Questions about this trial

What is this clinical trial studying?

An observational study of PDAC - Pancreatic Ductal Adenocarcinoma and Pancreatic Cancer Stage I, run by Immunovia, Inc..

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 9 inclusion and 3 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: opening soon, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 7-14 days following return of results). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07805681.

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 4 Sep 2026.

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