Clinical trial NCT06947395: Clinical Validation of a Blood Biomarker Test to Detect Early-Stage Pancreatic Cancer (VERIFI)
Official title: VERIFI: A Multicenter, Case-Control Clinical Validation Study of the Multiplex Blood Protein Biomarker Test, PancreaSure, for Early Detection of Pancreatic Ductal Adenocarcinoma (PDAC) in High-Risk Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer of the Pancreas
Pancreatic Cancer
Pancreas Neoplasms
Pancreatic Carcinoma Stage I
Pancreatic Carcinoma Stage II
Keywords: Early Detection of Cancer
Cancer Diagnostic
Early Detection of Pancreatic Cancer
Lead sponsor: Immunovia, Inc.
Sponsor class: INDUSTRY
First posted: 2025-04-27
Enrollment: 386
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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 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 PancreaSure, 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 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 ductal adenocarcinoma (PDAC) Stages I and II and non-PDAC controls of similar demographics who were at increased risk of PDAC because of their familial or genetic history. 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 a predefined (locked) algorithm with predefined (locked) cut-off 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 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 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: PancreaSure Sensitivity
timeFrame: Baseline
Secondary outcomes:
measure: PancreaSure Specificity
timeFrame: Baseline
measure: Performance versus CA19-9 alone
timeFrame: Baseline
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: HonorHealth Clinical Research Institute
state: Arizona
city: New York
country: United States
facility: New York University Langone Health
state: New York
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: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: UT Southwestern Medical Center
name: Patricio Polanco, MD
role: PRINCIPAL_INVESTIGATOR
References: