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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.
Full 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.
Enrollment
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Inclusion criteria
Informed consent available
> 45 years of age
PDAC cases
Controls
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
1,066 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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