[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654889":3},{"organization":4,"outcomesModule":7,"designInfo":38,"detailedDescription":41,"studyPopulation":42,"armGroups":43,"interventions":11,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":47,"collaborators":11,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":51,"sex":57,"minAge":58,"maxAge":11,"enrollmentInfo":59,"targetDuration":62,"studyType":63,"phases":11,"briefSummary":64,"conditions":65,"keywords":70,"overallStatus":77,"whyStopped":11,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":11},{"fullName":5,"class":6},"Immunovia, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":25},[9],{"measure":10,"description":11,"timeFrame":12},"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",null,"7-14 days following return of results",[14,17,21],{"measure":15,"description":11,"timeFrame":16},"Describing patterns of PancreaSure test utilization in clinical practice","0-12 Months Following Enrollment",{"measure":18,"description":19,"timeFrame":20},"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.","0-12 months following enrollment",{"measure":22,"description":23,"timeFrame":24},"Patient-reported outcomes","Perceived anxiety, satisfaction, and understanding of results. Barriers to testing","0- 12 months following enrollment",[26,30,34],{"measure":27,"description":28,"timeFrame":29},"Downstream healthcare utilization patterns potentially associated with PancreaSure testing","Medical records will be reviewed to describe healthcare utilization following PancreaSure testing. Measures will include recommendations for and completion of follow-up imaging or procedures; time to completion of first follow-up imaging; and documented decisions to defer or avoid imaging or invasive procedures following the test result. When available, reasons for delayed, deferred, or avoided follow-up will also be summarized, including clinical judgment, patient preference, and access or insurance barriers. Results will be reported using counts, percentages, and descriptive summaries, as appropriate.","From date PancreaSure is prescribed (t0) through 24 months after t0.",{"measure":31,"description":32,"timeFrame":33},"Clinical Outcomes During Follow-Up","Clinical outcomes observed during follow-up will be described. Among participants diagnosed with PDAC, measures will include stage at diagnosis; time in days from PancreaSure result availability to PDAC diagnosis; time in days from PancreaSure prescription to PDAC diagnosis; and survival status 12 months after diagnosis, when available. Stage and survival status will be reported using counts and percentages, and time-to-diagnosis measures will be summarized descriptively.","From the date PancreaSure is prescribed (t0) through 24 months after t0; survival status will be assessed 12 months after PDAC diagnosis when available.",{"measure":35,"description":36,"timeFrame":37},"Economic Outcomes Associated with PancreaSure Testing and Downstream Care","When financial or claims data are available, economic outcomes associated with PancreaSure testing and downstream diagnostic care will be described. Measures will include cumulative costs for PancreaSure testing, imaging, procedures, and specialty visits; cost per PDAC case detected during follow-up; insurance claim submission, approval, and denial patterns; allowed and paid amounts by payer type; and patient out-of-pocket expenses, including copayments, coinsurance, deductibles, and self-pay amounts. Cost per detected PDAC case will be calculated by dividing the cumulative cost of PancreaSure testing and selected downstream diagnostic services by the number of PDAC cases detected during follow-up. Monetary outcomes will be reported in U.S. dollars.","From the date PancreaSure is prescribed (t0) through 24 months after t0.",{"allocation":11,"interventionModel":11,"interventionModelDescription":11,"primaryPurpose":11,"observationalModel":39,"timePerspective":40,"maskingInfo":11},"COHORT","PROSPECTIVE","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.\n\nThe 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.\n\nThe study does not introduce experimental interventions, and all medical decisions remain at the discretion of the treating clinicians.","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:\n\n* Family history in ≥ 2 first-degree relatives, or\n* Known pathogenic germline mutation (BRCA1\u002F2, CDKN2A, PALB2, ATM, STK11, PRSS1), or\n* Pancreatic cystic lesion, or\n* New-onset diabetes with additional risk factors, or\n* Clinician discretion",[44],{"label":45,"type":11,"description":46,"interventionNames":11},"High Risk Individuals","Individuals who are considered at high-risk for developing pancreatic ductal adenocarcinoma.",{"type":48,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100654889","observational-registry-evaluating-the-clinical-impact-of-the-blood-based-biomarker-test-for-early-stage-pancreatic-ductal-adenocarcinoma-100654889",false,"NCT07805681","Observational Registry Evaluating the Clinical Impact of the Blood-Based Biomarker Test for Early-Stage Pancreatic Ductal Adenocarcinoma","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","ASSURE","Inclusion Criteria:\n\n* Able to provide informed written consent and complete the survey in English or Spanish\n* \\>45 years of age\n* PancreaSure ordered as part of routine clinical care.\n* At elevated risk for PDAC or is deemed appropriate for PDAC early detection testing based on:\n\n  * Family history in ≥ 2 first-degree relatives, or\n  * Known pathogenic germline mutation (BRCA1\u002F2, CDKN2A, PALB2, ATM, STK11, PRSS1), or\n  * Pancreatic cystic lesion, or\n  * New-onset diabetes with additional risk factors, or\n  * Clinician discretion\n\nExclusion Criteria:\n\n* Prior diagnosis of PDAC or other active malignancy within 3 years (except non-melanoma skin cancer).\n* Participation in interventional investigational studies that may bias test use.\n* Inability or unwillingness to comply with follow-up schedule.","ALL","45 Years",{"count":60,"type":61},400,"ESTIMATED","2 Years","OBSERVATIONAL","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.",[66,67,68,69],"PDAC - Pancreatic Ductal Adenocarcinoma","Pancreatic Cancer Stage I","Pancreatic Cancer Stage II","Cancer Diagnosis",[71,72,73,74,67,68,75,76],"Pancreatic Cancer Diagnosis","Pancreatic Cancer","PDAC","Early Detection","Pancreatic Ductal Adenocarcinoma","Pancreatic Cancer Detection","NOT_YET_RECRUITING","2026-09-01",{"date":80,"type":81},"2026-09-04","ACTUAL",{"date":83,"type":61},"2026-09",{"date":85,"type":61},"2029-04",{"name":5,"class":6}]