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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pancreatic Ductal Adenocarcinoma (PDAC) Stage I and Stage II Cases | 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. |
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| High-Risk Controls | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PancreaSure | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| PancreaSure Sensitivity | 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. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| PancreaSure Specificity | 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 | Baseline |
| Performance versus CA19-9 alone |
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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
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Samples will be retrospectively obtained under the Immunovia PanDetect, PanFam, or unique institutional protocols for sample collection through high-risk PDAC surveillance programs.
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| Name | Affiliation | Role |
|---|---|---|
| Patricio Polanco, MD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth Clinical Research Institute | Scottsdale | Arizona | 85258 | United States | ||
| New York University Langone Health |
Individual patient test results will not be shared with patients.
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Serum
|
Determine performance (sensitivity and specificity) of PancreaSure compared to CA19-9 alone in the overall population
| Baseline |
| New York |
| New York |
| 10016 |
| United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213-2582 | United States |
| Regional One Health | Memphis | Tennessee | 38103 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75235 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23284 | United States |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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