Trials / Completed

CompletedNCT06947382

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

Status: Completed
Phase: —
Study type: Observational
Enrollment: 1,066 (actual)

Sponsor: Immunovia, Inc. · Industry
Sex: All
Age: 45 Years
Healthy volunteers: Accepted

Summary

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.

Detailed description

This case-control study is being conducted to determine the performance of a multiplex protein biomarker model in human serum samples. Serum samples were collected for analysis from patients with Stages I and II pancreatic ductal adenocarcinoma (PDAC) and non-PDAC controls of similar demographics who were at increased risk of PDAC because their familial or genetic history or clinical symptoms. 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 three predefined (locked) algorithm with predefined (locked) cut-offs resulting in a positive/negative test outcome.

Conditions

Timeline

Start date: 2024-09-02
Primary completion: 2024-12-09
Completion: 2025-01-06
First posted: 2025-04-27
Last updated: 2025-04-27

Locations

15 sites across 4 countries: United States, Canada, Italy, Norway

Source: ClinicalTrials.gov record NCT06947382. Inclusion in this directory is not an endorsement.