Clinical Validation Of Immunovia Next-Generation Blood Biomarker Test To Detect Early-Stage Pancreatic Cancer

Study Overview

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

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.

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.

Pancreatic Cancer Stage I
Pancreatic Cancer Stage II
Cancer Diagnosis
PDAC - Pancreatic Ductal Adenocarcinoma

CLARITI-10

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2025-04-11	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-04-17
First Submitted that Met QC Criteria 2025-04-17	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-04-27
First Posted (ACTUAL) 2025-04-27	Results First Posted N/A	Last Verified 2025-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: 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.

Primary Outcome Measures	Measure Description	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	Measure Description	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
45 Years

Accepts Healthy Volunteers:
1

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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Clinical Trial Record