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

Immunovia

Status: Completed

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

Treatments: Diagnostic Test: PancreaSure

Study type: Observational

Funder types: Industry

Identifiers

NCT06947395

VERIFI-11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 386 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

• 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.

Trial design

386 participants in 2 patient groups

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

Description:

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.

Treatment:

Diagnostic Test: PancreaSure

High-Risk Controls

Description:

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.

Treatment:

Diagnostic Test: PancreaSure