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

NCT06947395 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 386

Last updated 2025-04-27

No results posted yet for this study

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

Interventions

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 negative detection of PDAC.

Sponsors & Collaborators

  • Immunovia, Inc.

    lead INDUSTRY

Principal Investigators

  • Patricio Polanco, MD · UT Southwestern Medical Center

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-11
Primary Completion
2025-03-24
Completion
2025-04-07

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06947395 on ClinicalTrials.gov