Clinical trial · Observational
Clinical Validation of a Blood Biomarker Test to Detect Early-Stage Pancreatic Cancer (VERIFI)
VERIFI: A Multicenter, Case-Control Clinical Validation Study of the Multiplex Blood Protein Biomarker Test, PancreaSure, for Early Detection of Pancreatic Ductal Adenocarcinoma (PDAC) in High-Risk Patients
- 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)
This is a case-control study to clinically validate the performance of PancreaSure, a protein biomarker test, to differentiate Stage I and Stage II pancreatic ductal adenocarcinoma (PDAC) patient samples from samples acquired from control patients not diagnosed with PDAC but at increased risk of disease due to familial/genetic history or clinical symptoms.
Conditions
Conditions (5)
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 of the Pancreas | Malignant Pancreatic Neoplasm | ALIAS | 0.90 |
| Pancreas Neoplasms | Pancreatic Neoplasm | ALIAS | 0.90 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Carcinoma Stage I | Pancreatic Carcinoma | CURATED_BROADER | 0.78 |
| Pancreatic Carcinoma Stage II | Pancreatic Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PancreaSure | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Pancreatic Ductal Adenocarcinoma (PDAC) Stage I and Stage II Cases
- description
- PDAC case samples will be obtained from patients with newly diagnosed, treatment- naive PDAC (Stages I and II). PDAC cases will include patients with familial/genetic or sporadic disease identified by the institution or referred to it for clinical management.
- interventionNames
- Diagnostic Test: PancreaSure
- label
- High-Risk Controls
- description
- Controls will consist of individuals who are at increased risk for PDAC because of their family history, known germline variants predisposing to PDAC, or the presence of pancreatic cystic lesions consistent with IPMNs. Note that cystic lesions between 1 and 3 cm are included in this study because PDAC risk with lesions less than 1 cm is quite low while lesions greater than 3 cm or with worrisome features by Fukuoka Consensus Guidelines have an appreciable risk of harboring an undiagnosed PDAC. All controls must have pancreatic imaging studies showing no evidence of PDAC within 6 months of sample collection.
- interventionNames
- Diagnostic Test: PancreaSure
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Informed consent available * \> 45 years of age * PDAC cases * Treatment-naïve, pathologically confirmed PDAC Stage I or Stage II * Sporadic or familial/genetic PDAC * Controls * Individuals at high risk for PDAC because of their familial and/or genetic history * Individuals at high risk for PDAC because of pancreatic cysts between 1.0cm and 3.0cm in diameter. * Controls will be selected to have similar demographic features (age/gender) to PDAC patients Exclusion Criteria: * Prior treatment for PDAC (i.e., prior resection, radiotherapy, or chemotherapy) * Current immunosuppressive (e.g., systemic steroid therapy) or chemotherapy * Major surgery or significant trauma within 12 weeks prior to blood sample collection * Non-PDAC malignancies within 3 years prior to sample collection squamous or basal cell skin carcinoma is not an exclusion criteria) * Control patients who currently have * biliary obstruction secondary to gallstones * prior diagnosis or imaging evidence of chronic pancreatitis * cystic pancreatic lesions \>3.0 cm in diameter or showing worrisome features according to Fukuoka Consensus Guidelines.
References
Publications (0)
Data not yet available