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| Name | Class |
|---|---|
| Corewell Health West | OTHER |
| Mercy Health | OTHER |
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This is a non-treatment, blood collection study to evaluate biomarker panels for the diagnosis and prognosis of pancreatic cancer.
This is a non-treatment, blood collection study to evaluate biomarker panels for the diagnosis and prognosis of pancreatic cancer.
Study participants will be recruited by physician referral or from a list of clinical patients being evaluated for a potential pancreatic abnormality or for potential treatment of pancreatic cancer. Additionally, a surveillance cohort will be recruited among individuals who are being monitored for recurrence following surgical or medical treatment for pancreatic cancer.
Peripheral blood specimens will be collected from all participants at time of enrollment. Additional specimens may be collected from surveillance cohort participants no more frequently than once every 3 months as clinically indicated.
The specimens will be sent to a clinical lab for sTRA biomarker and CA19-9 analysis. Participants will be followed for 36 months to track clinical outcomes. The performance of the investigation biomarker for the diagnosis, prognosis, or surveillance of pancreatic cancer will be compared to the performance of CA19-9.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic/prognostic cohort | Patients being evaluated for a potential pancreatic abnormality or for potential treatment for pancreatic adenocarcinoma. | ||
| Surveillance Cohort | Patients who are being monitored for recurrence following surgical or medical treatment for pancreatic adenocarcinoma |
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| Measure | Description | Time Frame |
|---|---|---|
| Diagnosis of adenocarcinoma of the pancreas | Number of patients clinically diagnosed with pancreatic adenocarcinoma | Up to three years |
| Investigational biomarker panel for diagnosis | sTRA biomarker and CA 19-9 levels at enrollment | Enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Disease progression | Disease progression of pancreatic adenocarcinoma as measured by RESIST v1.1 criteria | Up to three years |
| Investigational biomarker panel for disease surveillance | sTRA biomarker and CA 19-9 levels measured at any time point deemed clinically relevant for standard of care. |
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Inclusion Criteria:
Diagnosis/Prognosis Cohort
Surveillance Cohort
Exclusion Criteria:
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Participants will be recruited from collaborating clinical sites by screening physician schedules and through physician referral.
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| Name | Affiliation | Role |
|---|---|---|
| Brian Haab, PhD | Van Andel Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mercy Health Saint Mary's Hospital | Grand Rapids | Michigan | 49503 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30617132 | Background | Staal B, Liu Y, Barnett D, Hsueh P, He Z, Gao C, Partyka K, Hurd MW, Singhi AD, Drake RR, Huang Y, Maitra A, Brand RE, Haab BB. The sTRA Plasma Biomarker: Blinded Validation of Improved Accuracy Over CA19-9 in Pancreatic Cancer Diagnosis. Clin Cancer Res. 2019 May 1;25(9):2745-2754. doi: 10.1158/1078-0432.CCR-18-3310. Epub 2019 Jan 7. |
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Peripheral blood specimens
| Up to three years |