Clinical trial NCT06947382: Clinical Validation of Immunovia Next-Generation Blood Biomarker Test to Detect Early-Stage Pancreatic Cancer
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer Stage I
Pancreatic Cancer Stage II
Cancer Diagnosis
PDAC - Pancreatic Ductal Adenocarcinoma
Keywords: PDAC
pancreatic cancer
early detection
Pancreatic Cancer Stage I
Pancreatic Cancer Stage II
pancreatic cancer diagnosis
pancreatic ductal adenocarcinoma
pancreatic cancer detection
Lead sponsor: Immunovia, Inc.
Sponsor class: INDUSTRY
First posted: 2025-04-27
Enrollment: 1066
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Samples will be retrospectively obtained under the Immunovia PanDetect, PanFam or PRECEDE study protocols, or unique institutional protocols for sample collection through high-risk PDAC surveillance programs.

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 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 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 Stages I and II pancreatic ductal adenocarcinoma (PDAC) and non-PDAC controls of similar demographics who were at increased risk of PDAC because their familial or genetic history or clinical symptoms. 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 three predefined (locked) algorithm with predefined (locked) cut-offs resulting in a positive/negative test outcome.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Determine the sensitivity and specificity of IMMNOV-2 to differentiate serum samples from patients diagnosed with PDAC and controls.
timeFrame: Baseline
Secondary outcomes:
measure: Sensitivity and specificity of IMMNOV-2 compared to sensitivity and specificity of CA19-9 alone in the overall population
timeFrame: Baseline
measure: Sensitivity and specificity of IMMNOV-2 in patients age > or equal to 65 years of age
timeFrame: Baseline
measure: Sensitivity and specificity of IMMNOV-2 compared to sensitivity and specificity of CA19-9 alone in patients age > or equal to 65 years old
timeFrame: Baseline
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: HonorHealth Clinical Research Institute
state: Arizona
city: Burbank
country: United States
facility: St. John's Cancer Institute
state: California
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Stanford
country: United States
facility: Stanford Gastroenterology and Hepatology
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Memphis
country: United States
facility: Regional One Health
state: Tennessee
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Montréal
country: Canada
facility: The Research Institute of the McGill University Health Centre
city: Verona
country: Italy
facility: University of Verona
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
References: