Clinical Validation of Immunovia Next-Generation Blood Biomarker Test to Detect Early-Stage Pancreatic Cancer
Completed
Conditions studied: Pancreatic Cancer Stage I, Pancreatic Cancer Stage II, Cancer Diagnosis, PDAC - Pancreatic Ductal Adenocarcinoma
In brief
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.
Key facts
- Study ID
- NCT06947382
- Run by
- Immunovia, Inc.
- People needed
- 1066
- Starts
- 2024-09-02
- Expected to finish
- 2025-01-06
- Last updated by the study team
- 2025-04-27
Who can join
Age: 45 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- HonorHealth Clinical Research Institute — Scottsdale, Arizona, United States
- St. John's Cancer Institute — Burbank, California, United States
- University of California San Diego — La Jolla, California, United States
- Stanford Gastroenterology and Hepatology — Stanford, California, United States
- University of Miami — Miami, Florida, United States
- University of Chicago Medical Center — Chicago, Illinois, United States
- Mount Sinai Hospital — New York, New York, United States
- Oregon Health Sciences University — Portland, Oregon, United States
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
- Regional One Health — Memphis, Tennessee, United States
- Inova Schar Cancer Institute — Fairfax, Virginia, United States
- Virginia Commonwealth University — Richmond, Virginia, United States
- The Research Institute of the McGill University Health Centre — Montreal, Canada
- University of Verona — Verona, Italy
- Oslo University Hospital — Oslo, Norway
Full record on ClinicalTrials.gov
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