Cancer of the Pancreas, Pancreas Neoplasms, Pancreatic Cancer, Pancreatic Carcinoma Stage I, Pancreatic Carcinoma Stage II
Conditions
Keywords
Early Detection of Cancer, Cancer Diagnostic, Early Detection of Pancreatic Cancer
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.
Detailed 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.
Interventions
DIAGNOSTIC_TESTPancreaSure
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
Immunovia, Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PancreaSure Sensitivity | Baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PancreaSure Specificity | Baseline | Determine specificity of PancreaSure in the classification of serum samples from control subjects as negative for PDAC, in a study sample containing both PDAC and control samples |
| Performance versus CA19-9 alone | Baseline | Determine performance (sensitivity and specificity) of PancreaSure compared to CA19-9 alone in the overall population |
Countries
United States
Outcome results
None listed