Cancer Diagnosis, Pancreatic Cancer Stage I, Pancreatic Cancer Stage II, PDAC - Pancreatic Ductal Adenocarcinoma
Conditions
Keywords
PDAC, pancreatic cancer, early detection, Pancreatic Cancer Stage I, Pancreatic Cancer Stage II, pancreatic cancer diagnosis, pancreatic ductal adenocarcinoma, pancreatic cancer detection
Brief summary
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.
Detailed description
This case-control study is being conducted to determine the performance of a multiplex protein biomarker model in human serum samples. Serum samples were collected for analysis from patients with Stages I and II pancreatic ductal adenocarcinoma (PDAC) and non-PDAC controls of similar demographics who were at increased risk of PDAC because their familial or genetic history or clinical symptoms. 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 three predefined (locked) algorithm with predefined (locked) cut-offs resulting in a positive/negative test outcome.
Interventions
None listed
Sponsors
Immunovia, Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
Yes
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 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.
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 |
|---|---|
| Determine the sensitivity and specificity of IMMNOV-2 to differentiate serum samples from patients diagnosed with PDAC and controls. | Baseline |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity and specificity of IMMNOV-2 in patients age > or equal to 65 years of age | Baseline |
| Sensitivity and specificity of IMMNOV-2 compared to sensitivity and specificity of CA19-9 alone in the overall population | Baseline |
| Sensitivity and specificity of IMMNOV-2 compared to sensitivity and specificity of CA19-9 alone in patients age > or equal to 65 years old | Baseline |
Countries
Canada, Italy, Norway, United States
Outcome results
None listed