Status:
COMPLETED
Clinical Validation of Immunovia Next-Generation Blood Biomarker Test to Detect Early-Stage Pancreatic Cancer
Lead Sponsor:
Immunovia, Inc.
Conditions:
Pancreatic Cancer Stage I
Pancreatic Cancer Stage II
Eligibility:
All Genders
45+ years
Brief 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 sampl...
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 Sta...
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 with clinical symptoms/signs (e.g. abnormal imaging of the pancreas such as fullness, unexplained weight loss, etc) suggestive of PDAC who were found to NOT have PDAC based on clinical investigation (imaging evidence within 6 months of blood draw)
- Controls will be selected to have similar demographic features (age/gender) to PDAC patients, as possible.
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 :
September 2 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 6 2025
Estimated Enrollment :
1066 Patients enrolled
Trial Details
Trial ID
NCT06947382
Start Date
September 2 2024
End Date
January 6 2025
Last Update
April 27 2025
Active Locations (15)
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1
HonorHealth Clinical Research Institute
Scottsdale, Arizona, United States, 85258
2
St. John's Cancer Institute
Burbank, California, United States, 91505
3
University of California San Diego
La Jolla, California, United States, 92093
4
Stanford Gastroenterology and Hepatology
Stanford, California, United States, 94305