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

NCT ID: NCT06947395

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 386 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-11
• Study Completion Date: 2025-04-07

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.

Conditions

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

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 management.

PancreaSure

Intervention Type: DIAGNOSTIC_TEST

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 negative detection of PDAC.

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 and 3 cm are included in this study because PDAC risk with lesions less than 1 cm is quite low while lesions greater than 3 cm or with worrisome features by Fukuoka Consensus Guidelines have an appreciable risk of harboring an undiagnosed PDAC. All controls must have pancreatic imaging studies showing no evidence of PDAC within 6 months of sample collection.

PancreaSure

Intervention Type: DIAGNOSTIC_TEST

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 negative detection of PDAC.

Interventions

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 negative detection of PDAC.

Intervention Type: DIAGNOSTIC_TEST

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
• 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.

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Immunovia, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patricio Polanco, MD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Locations

HonorHealth Clinical Research Institute

Scottsdale, Arizona, United States

New York University Langone Health

New York, New York, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Regional One Health

Memphis, Tennessee, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Other Identifiers

VERIFI-11

Identifier Type: -

Identifier Source: org_study_id