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

NCT06947395 | Completed

• 1 other identifier: VERIFI-11
• Study Type: observational
• Target: 386
• Locations: 1 country
• Sites: 6

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.

Conditions

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

Keywords

Early Detection of Cancer; Cancer Diagnostic; Early Detection of Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• PancreaSure Specificity

  Baseline

• Performance versus CA19-9 alone

  Baseline

Study Arms (2)

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.

Diagnostic Test: PancreaSure

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.

Diagnostic Test: PancreaSure

Interventions

PancreaSure 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; Pancreatic Ductal Adenocarcinoma (PDAC) Stage I and Stage II Cases

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• 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 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 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

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 (6)

HonorHealth Clinical Research Institute

Scottsdale, Arizona, 85258, United States

Location

New York University Langone Health

New York, New York, 10016, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213-2582, United States

Location

Regional One Health

Memphis, Tennessee, 38103, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75235, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23284, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

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 Officials

• Patricio Polanco, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

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: February 11, 2025
• Primary Completion: March 24, 2025
• Study Completion: April 7, 2025
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)