Clinical Validation of Immunovia Next-Generation Blood Biomarker Test to Detect Early-Stage Pancreatic Cancer (CLARITI)

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

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.

Study Overview

• Status: Completed
• Conditions: PDAC - Pancreatic Ductal Adenocarcinoma; Cancer Diagnosis; Pancreatic Cancer Stage II; Pancreatic Cancer Stage I

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.

• Study Type: Observational
• Enrollment (Actual): 1066

Contacts and Locations

Study Locations

• Canada
  • Montréal, Canada
    • The Research Institute of the McGill University Health Centre
• Italy
  • Verona, Italy
    • University of Verona
• Norway
  • Oslo, Norway
    • Oslo University Hospital
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • HonorHealth Clinical Research Institute
  • California
    • Burbank, California, United States, 91505
      • St. John's Cancer Institute
    • La Jolla, California, United States, 92093
      • University of California San Diego
    • Stanford, California, United States, 94305
      • Stanford Gastroenterology and Hepatology
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center
  • New York
    • New York, New York, United States, 10029-6574
      • Mount Sinai Hospital
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health Sciences University
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213-2582
      • University of Pittsburgh Medical Center
  • Tennessee
    • Memphis, Tennessee, United States, 38103
      • Regional One Health
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • INOVA Schar Cancer Institute
    • Richmond, Virginia, United States, 23284
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
PDAC Cases; Serum samples from patients recently diagnosed with Stage I or Stage II pancreatic adenocarcinoma (PDAC) with no prior treatment for disease
Control; Serum samples from non-pancreatic adenocarcinoma (PDAC) patients at high-risk for disease due to familial or genetic history or clinical symptoms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Determine the sensitivity and specificity of IMMNOV-2 to differentiate serum samples from patients diagnosed with PDAC and controls.	Baseline

Secondary Outcome Measures

Outcome Measure	Time Frame
Sensitivity and specificity of IMMNOV-2 compared to sensitivity and specificity of CA19-9 alone in the overall population	Baseline
Sensitivity and specificity of IMMNOV-2 in patients age > or equal to 65 years of age	Baseline
Sensitivity and specificity of IMMNOV-2 compared to sensitivity and specificity of CA19-9 alone in patients age > or equal to 65 years old	Baseline

Collaborators and Investigators

• Sponsor: Immunovia, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2024
• Primary Completion (Actual): December 9, 2024
• Study Completion (Actual): January 6, 2025

Study Registration Dates

• First Submitted: April 11, 2025
• First Submitted That Met QC Criteria: April 17, 2025
• First Posted (Actual): April 27, 2025

Study Record Updates

• Last Update Posted (Actual): April 27, 2025
• Last Update Submitted That Met QC Criteria: April 17, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: early detection; pancreatic cancer; PDAC; pancreatic ductal adenocarcinoma; Pancreatic Cancer Stage I; Pancreatic Cancer Stage II; pancreatic cancer diagnosis; pancreatic cancer detection
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Neoplasms, Glandular and Epithelial; Carcinoma; Pancreatic Neoplasms; Adenocarcinoma
• Other Study ID Numbers: CLARITI-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual patient results will not be shared with patients.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes