Clinical Validation of Immunovia Next-Generation Blood Biomarker Test to Detect Early-Stage Pancreatic Cancer

Description

This is a case-control study to clinically validate the performance of 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

Pancreatic Cancer Stage I, Pancreatic Cancer Stage II, Cancer Diagnosis, PDAC - Pancreatic Ductal Adenocarcinoma

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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 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.

Multicenter, Case-Control Clinical Validation Study of a Multiplex Blood Protein Biomarker Test, IMMNOV-2, for Early Detection of Pancreatic Ductal Adenocarcinoma (PDAC) in High-Risk Patients

Clinical Validation of Immunovia Next-Generation Blood Biomarker Test to Detect Early-Stage Pancreatic Cancer

Condition
Pancreatic Cancer Stage I
Intervention / Treatment

-

Contacts and Locations

Scottsdale

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

Burbank

St. John's Cancer Institute, Burbank, California, United States, 91505

La Jolla

University of California San Diego, La Jolla, California, United States, 92093

Stanford

Stanford Gastroenterology and Hepatology, Stanford, California, United States, 94305

Miami

University of Miami, Miami, Florida, United States, 33136

Chicago

University of Chicago Medical Center, Chicago, Illinois, United States, 60637

New York

Mount Sinai Hospital, New York, New York, United States, 10029-6574

Portland

Oregon Health Sciences University, Portland, Oregon, United States, 97239

Pittsburgh

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

Memphis

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

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 with clinical symptoms/signs (e.g. abnormal imaging of the pancreas such as fullness, unexplained weight loss, etc) suggestive of PDAC who were found to NOT have PDAC based on clinical investigation (imaging evidence within 6 months of blood draw)
  • * Controls will be selected to have similar demographic features (age/gender) to PDAC patients, as possible.
  • * 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

Yes

Collaborators and Investigators

Immunovia, Inc.,

Study Record Dates

2025-01-06