MedPath

Clinical Validation of a Blood Biomarker Test to Detect Early-Stage Pancreatic Cancer (VERIFI)

Completed
Conditions
Cancer of the Pancreas
Pancreatic Cancer
Pancreas Neoplasms
Pancreatic Carcinoma Stage I
Pancreatic Carcinoma Stage II
Registration Number
NCT06947395
Lead Sponsor
Immunovia, Inc.
Brief 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
386
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.

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
PancreaSure SensitivityBaseline

Determine the sensitivity of PancreaSure in the classification of serum samples from patients diagnosed with PDAC as positive for PDAC, in a study sample containing both PDAC and control samples.

Secondary Outcome Measures
NameTimeMethod
PancreaSure SpecificityBaseline

Determine specificity of PancreaSure in the classification of serum samples from control subjects as negative for PDAC, in a study sample containing both PDAC and control samples

Performance versus CA19-9 aloneBaseline

Determine performance (sensitivity and specificity) of PancreaSure compared to CA19-9 alone in the overall population

Trial Locations

Locations (6)

HonorHealth Clinical Research Institute

🇺🇸

Scottsdale, Arizona, United States

New York University Langone Health

🇺🇸

New York, New York, United States

University of Pittsburgh Medical Center

🇺🇸

Pittsburgh, Pennsylvania, United States

Regional One Health

🇺🇸

Memphis, Tennessee, United States

UT Southwestern Medical Center

🇺🇸

Dallas, Texas, United States

Virginia Commonwealth University

🇺🇸

Richmond, Virginia, United States

HonorHealth Clinical Research Institute
🇺🇸Scottsdale, Arizona, United States

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.