Status:
COMPLETED
Clinical Validation of a Blood Biomarker Test to Detect Early-Stage Pancreatic Cancer (VERIFI)
Lead Sponsor:
Immunovia, Inc.
Conditions:
Cancer of the Pancreas
Pancreatic Cancer
Eligibility:
All Genders
45+ years
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 samp...
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 duct...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 11 2025
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 7 2025
Estimated Enrollment :
386 Patients enrolled
Trial Details
Trial ID
NCT06947395
Start Date
February 11 2025
End Date
April 7 2025
Last Update
April 27 2025
Active Locations (6)
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1
HonorHealth Clinical Research Institute
Scottsdale, Arizona, United States, 85258
2
New York University Langone Health
New York, New York, United States, 10016
3
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213-2582
4
Regional One Health
Memphis, Tennessee, United States, 38103