NCT06947382Completed
Clinical Validation of Immunovia Next-Generation Blood Biomarker Test to Detect Early-Stage Pancreatic Cancer
Multicenter, Case-Control Clinical Validation Study of a Multiplex Blood Protein Biomarker Test, IMMNOV-2, for Early Detection of Pancreatic Ductal Adenocarcinoma (PDAC) in High-Risk Patients
Source: ClinicalTrials.gov · Last updated 27 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 1066 (actual)
- First submitted
- 11 Apr 2025
- Start date
- 2 Sept 2024
- Primary completion date
- 9 Dec 2024
- Lead sponsor
- Immunovia, Inc.
- Diseases
- Pancreatic cancer
- NCT number
- NCT06947382
What you commit to
- Study type: Observational
- Participants enrolled: 1066
- From 2 Sept 2024 to the primary completion date, 9 Dec 2024
- 15 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Who the study is looking for
- 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.
Age in the registry: 45 years to - · Sex: All · Accepts healthy volunteers
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Research Institute of the McGill University Health Centre Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| University of Verona Coordinator of this site? Confirm its status | Verona | Italy | Unknown status |
| Oslo University Hospital Coordinator of this site? Confirm its status | Oslo | Norway | Unknown status |
| St. John's Cancer Institute Coordinator of this site? Confirm its status | Burbank | United States | Unknown status |
| University of Chicago Medical Center Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Inova Schar Cancer Institute Coordinator of this site? Confirm its status | Fairfax | United States | Unknown status |
| University of California San Diego Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
| Regional One Health Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
| University of Miami Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Mount Sinai Hospital Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| University of Pittsburgh Medical Center Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Oregon Health Sciences University Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Virginia Commonwealth University Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| HonorHealth Clinical Research Institute Coordinator of this site? Confirm its status | Scottsdale | United States | Unknown status |
| Stanford Gastroenterology and Hepatology Coordinator of this site? Confirm its status | Stanford | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.