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

Description

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

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Study Overview

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Study Details

Study overview

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.

VERIFI: A Multicenter, Case-Control Clinical Validation Study of the Multiplex Blood Protein Biomarker Test, PancreaSure, for Early Detection of Pancreatic Ductal Adenocarcinoma (PDAC) in High-Risk Patients

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

Condition
Cancer of the Pancreas
Intervention / Treatment

-

Contacts and Locations

Scottsdale

HonorHealth Clinical Research Institute, Scottsdale, Arizona, United States, 85258

New York

New York University Langone Health, New York, New York, United States, 10016

Pittsburgh

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States, 15213-2582

Memphis

Regional One Health, Memphis, Tennessee, United States, 38103

Dallas

UT Southwestern Medical Center, Dallas, Texas, United States, 75235

Richmond

Virginia Commonwealth University, Richmond, Virginia, United States, 23284

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

45 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Immunovia, Inc.,

Patricio Polanco, MD, PRINCIPAL_INVESTIGATOR, UT Southwestern Medical Center

Study Record Dates

2025-04-07