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

NCT06947382 | Completed

• 1 other identifier: CLARITI-10
• Study Type: observational
• Target: 1,066
• Locations: 4 countries
• Sites: 15

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.

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

Outcome Measures

Primary Outcomes (1)

• Determine the sensitivity and specificity of IMMNOV-2 to differentiate serum samples from patients diagnosed with PDAC and controls.

  Baseline

Secondary Outcomes (3)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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
• 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.

Sponsors & Collaborators

• Immunovia, Inc.: lead

Study Sites (15)

HonorHealth Clinical Research Institute

Scottsdale, Arizona, 85258, United States

Location

St. John's Cancer Institute

Burbank, California, 91505, United States

Location

University of California San Diego

La Jolla, California, 92093, United States

Location

Stanford Gastroenterology and Hepatology

Stanford, California, 94305, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Mount Sinai Hospital

New York, New York, 10029-6574, United States

Location

Oregon Health Sciences University

Portland, Oregon, 97239, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213-2582, United States

Location

Regional One Health

Memphis, Tennessee, 38103, United States

Location

Inova Schar Cancer Institute

Fairfax, Virginia, 22031, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23284, United States

Location

The Research Institute of the McGill University Health Centre

Montreal, Canada

Location

University of Verona

Verona, Italy

Location

Oslo University Hospital

Oslo, Norway

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 27, 2025
• Study Start: September 2, 2024
• Primary Completion: December 9, 2024
• Study Completion: January 6, 2025
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (12); CA (1); IT (1); NO (1)