Clinical Validation Of A Blood Biomarker Test To Detect Early-Stage Pancreatic Cancer (VERIFI)

Study Overview

Clinical Validation of a Blood Biomarker Test to Detect Early-Stage Pancreatic Cancer (VERIFI)

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.

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.

Cancer of the Pancreas
Pancreatic Cancer
Pancreas Neoplasms
Pancreatic Carcinoma Stage I
Pancreatic Carcinoma Stage II

DIAGNOSTIC_TEST: PancreaSure

VERIFI-11

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
: Pancreatic Ductal Adenocarcinoma (PDAC) Stage I and Stage II Cases PDAC case samples will be obtained from patients with newly diagnosed, treatment- naive PDAC (Stages I and II). PDAC cases will include patients with familial/genetic or sporadic disease identified by the institution or referred to it for clinical managem	DIAGNOSTIC_TEST: PancreaSure Serum-based biomarker test comprised of ELISA-based analyte readings of 4 protein biomarkers (ICAM-1, TIMP1, THSB1, and CTSD) and CA19-9 summed by a mathematical algorithm with associated coefficients where a pre-defined cutoff establishes a positive or n
: High-Risk Controls Controls will consist of individuals who are at increased risk for PDAC because of their family history, known germline variants predisposing to PDAC, or the presence of pancreatic cystic lesions consistent with IPMNs. Note that cystic lesions between 1 a	DIAGNOSTIC_TEST: PancreaSure Serum-based biomarker test comprised of ELISA-based analyte readings of 4 protein biomarkers (ICAM-1, TIMP1, THSB1, and CTSD) and CA19-9 summed by a mathematical algorithm with associated coefficients where a pre-defined cutoff establishes a positive or n

Participant Group/Arm

Intervention/Treatment

: Pancreatic Ductal Adenocarcinoma (PDAC) Stage I and Stage II Cases

PDAC case samples will be obtained from patients with newly diagnosed, treatment- naive PDAC (Stages I and II). PDAC cases will include patients with familial/genetic or sporadic disease identified by the institution or referred to it for clinical managem

DIAGNOSTIC_TEST: PancreaSure

Serum-based biomarker test comprised of ELISA-based analyte readings of 4 protein biomarkers (ICAM-1, TIMP1, THSB1, and CTSD) and CA19-9 summed by a mathematical algorithm with associated coefficients where a pre-defined cutoff establishes a positive or n

: High-Risk Controls

Controls will consist of individuals who are at increased risk for PDAC because of their family history, known germline variants predisposing to PDAC, or the presence of pancreatic cystic lesions consistent with IPMNs. Note that cystic lesions between 1 a

DIAGNOSTIC_TEST: PancreaSure

Serum-based biomarker test comprised of ELISA-based analyte readings of 4 protein biomarkers (ICAM-1, TIMP1, THSB1, and CTSD) and CA19-9 summed by a mathematical algorithm with associated coefficients where a pre-defined cutoff establishes a positive or n

Primary Outcome Measures	Measure Description	Time Frame
PancreaSure Sensitivity	Determine the sensitivity of PancreaSure in the classification of serum samples from patients diagnosed with PDAC as positive for PDAC, in a study sample containing both PDAC and control samples.	Baseline

Secondary Outcome Measures	Measure Description	Time Frame
PancreaSure Specificity	Determine specificity of PancreaSure in the classification of serum samples from control subjects as negative for PDAC, in a study sample containing both PDAC and control samples	Baseline
Performance versus CA19-9 alone	Determine performance (sensitivity and specificity) of PancreaSure compared to CA19-9 alone in the overall population	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:

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

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.

Investigators

PRINCIPAL_INVESTIGATOR: Patricio Polanco, MD, UT Southwestern Medical Center

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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Resources

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Clinical Trial Record