Observational Registry Evaluating the Clinical Impact of the Blood-Based Biomarker Test for Early-Stage Pancreatic Ductal Adenocarcinoma

N/ANot Yet RecruitingNCT07805681

Immunovia, Inc.400 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

400

Conditions

PDAC - Pancreatic Ductal Adenocarcinoma

Eligibility

Sex: ALLMin age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 * Pancreatic cystic lesion, or * New-onset diabetes with additional risk factors, or * Clinician discretion Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

Describing patterns of PancreaSure test utilization in clinical practice

Time frame: 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.

Time frame: 0-12 months following enrollment

Patient-reported outcomes

Perceived anxiety, satisfaction, and understanding of results. Barriers to testing

Time frame: 0- 12 months following enrollment