Trials / Completed
CompletedNCT06947395
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 386 (actual)
- Sponsor
- Immunovia, Inc. · Industry
- Sex
- All
- Age
- 45 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
This is the second case-control study to clinically validate the multi- analyte biomarker diagnostic model, PancreaSure. Serum samples will be collected for analysis from patients with pancreatic ductal adenocarcinoma (PDAC) Stages I and II and non-PDAC controls of similar demographics who were at increased risk of PDAC because of their familial or genetic history. Investigators and patients will not receive individual patient results, therefore patient care will not be impacted by test results. Analysis of blood samples will be conducted in Immunovia's laboratory in Durham, NC by personnel who are blinded to subject data. Biomarker results will be analyzed using a predefined (locked) algorithm with predefined (locked) cut-off resulting in a positive/negative test outcome.
Conditions
- Cancer of the Pancreas
- Pancreatic Cancer
- Pancreas Neoplasms
- Pancreatic Carcinoma Stage I
- Pancreatic Carcinoma Stage II
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | PancreaSure | Serum-based biomarker test comprised of ELISA-based analyte readings of 4 protein biomarkers (ICAM-1, TIMP1, THSB1, and CTSD) and CA19-9 summed by a mathematical algorithm with associated coefficients where a pre-defined cutoff establishes a positive or negative detection of PDAC. |
Timeline
- Start date
- 2025-02-11
- Primary completion
- 2025-03-24
- Completion
- 2025-04-07
- First posted
- 2025-04-27
- Last updated
- 2025-04-27
Locations
6 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT06947395. Inclusion in this directory is not an endorsement.