Clinical Validation of a Blood Biomarker Test to Detect Early-Stage Pancreatic Cancer (VERIFI)
- Conditions
- Cancer of the PancreasPancreatic CancerPancreas NeoplasmsPancreatic Carcinoma Stage IPancreatic 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
-
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
-
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
Name Time Method PancreaSure Sensitivity Baseline 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
Name Time Method PancreaSure Specificity Baseline 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 alone Baseline 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