Clinical trial · Observational
Clinical Validation of Immunovia Next-Generation Blood Biomarker Test to Detect Early-Stage Pancreatic Cancer
Multicenter, Case-Control Clinical Validation Study of a Multiplex Blood Protein Biomarker Test, IMMNOV-2, 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 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 (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 (2)
- label
- PDAC Cases
- description
- Serum samples from patients recently diagnosed with Stage I or Stage II pancreatic adenocarcinoma (PDAC) with no prior treatment for disease
- label
- Control
- description
- Serum samples from non-pancreatic adenocarcinoma (PDAC) patients at high-risk for disease due to familial or genetic history or clinical symptoms.
Primary outcomes (1)
- measure
- Determine the sensitivity and specificity of IMMNOV-2 to differentiate serum samples from patients diagnosed with PDAC and controls.
- timeFrame
- Baseline
Secondary outcomes (3)
- measure
- Sensitivity and specificity of IMMNOV-2 compared to sensitivity and specificity of CA19-9 alone in the overall population
- timeFrame
- Baseline
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 with clinical symptoms/signs (e.g. abnormal imaging of the pancreas such as fullness, unexplained weight loss, etc) suggestive of PDAC who were found to NOT have PDAC based on clinical investigation (imaging evidence within 6 months of blood draw) * Controls will be selected to have similar demographic features (age/gender) to PDAC patients, as possible. 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