Pancreatic Cancer Biomarker Study

Study Overview
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Brief Summary
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This is a non-treatment, blood collection study to evaluate biomarker panels for the diagnosis and prognosis of pancreatic cancer.

Detailed Description
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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.

Official Title
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Evaluation of a Biomarker Panel for the Diagnosis and Prognosis of Pancreatic Cancer

Conditions
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Pancreatic Adenocarcinoma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis/Prognosis Cohort Patients being evaluated for possible pancreatic abnormality, via additional radiological test (endoscopic ultrasound, abdominal CT scan), blood test (CA19-9), or other diagnostic procedure. Patients being evaluated for medical or surgical treatment for pancreatic cancer or pancreatitis on the basis of previous clinical and radiological findings. Surveillance Cohort Patients being monitored or who will be monitored for potential recurrence of pancreatic cancer following surgical or medical treatment of pancreatic adenocarcinoma. Exclusion Criteria: The participant is unwilling or unable to provide written informed consent. In the investigator's opinion, the participant is unsuitable for the study. The participant does not speak English. The participant is a prisoner. The participant is known to be pregnant. The participant is less than 18 years of age.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diagnostic/prognostic cohort<br>Patients being evaluated for a potential pancreatic abnormality or for potential treatment for pancreatic adenocarcinoma. | |
| Surveillance Cohort<br>Patients who are being monitored for recurrence following surgical or medical treatment for pancreatic adenocarcinoma | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | Up to three years |