Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Diagnosis | — | UNRESOLVED | — |
| Pancreatic Cancer Stage I | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Pancreatic Cancer Stage II | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| PDAC - Pancreatic Ductal Adenocarcinoma | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- High Risk Individuals
- description
- Individuals who are considered at high-risk for developing pancreatic ductal adenocarcinoma.
Primary outcomes (1)
- 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
- timeFrame
- 7-14 days following return of results
Secondary outcomes (3)
- measure
- Describing patterns of PancreaSure test utilization in clinical practice
- timeFrame
- 0-12 Months Following Enrollment
- measure
- Downstream clinical actions and follow-through
- timeFrame
- 0-12 months following enrollment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available