Observational Study of ctDNA in Resectable and Borderline Resectable Pancreatic Cancer

Study Overview
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Brief Summary
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The purpose of this study is to collect information about treatment recommendations based on ctDNA testing and whether treatment changes based on ctDNA information result in better outcomes for patients with pancreatic cancer.

Official Title
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Observational Study of ctDNA in Resectable and Borderline Resectable Pancreatic Cancer

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Other: SIGNATERA™ ctDNA testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older Resectable or borderline resectable pancreatic adenocarcinoma per NCNN guidelines No prior radiation therapy, chemotherapy, targeted therapy, investigational therapy, or surgery for pancreatic cancer. ECOG performance status ≤ 1 Clinically eligible for chemotherapy Able to tolerate collection of up to 20 mL of blood via venipuncture for research blood draw Has residual FFPE specimen available for submission to Natera Able to read, understand and provide written informed consent Willing and able to comply with the study requirements Exclusion Criteria: Pregnant or breastfeeding Radiologic evidence of distant metastases Prior history and treatment for any cancer within the past year or has another active cancer, with the exception of non-melanoma skin cancer Prior initiation of chemotherapy, radiation therapy, or surgery for pancreatic cancer Neuropathy > grade 2 History of bone marrow or organ transplant Blood transfusion within 1 month of enrollment Medical condition that would place the patient at risk as a result of blood donation, such as bleeding disorder Serious medical condition that may adversely affect ability to participate in the study

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

| Intervention/Treatment |
| --- |
|Other: SIGNATERA™ ctDNA testing|Information collection about how SIGNATERA™ ctDNA testing changes how doctors make treatment recommendations to patients with early-stage pancreatic cancer.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of SIGNATERA™ on treatment decisions | Examine the impact of SIGNATERA™ on treatment decisions as determined by physician questionnaires | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of positive SIGNATERA™ ctDNA testing | Determine the frequency of positive SIGNATERA™ ctDNA testing in patients with R/BR PDAC at baseline and after surgical resection | 2 years | 
| Overall survival of patients managed with SIGNATERA™ ctDNA data | Compare overall survival of patients managed with available SIGNATERA™ ctDNA data to historical controls | 2 years | 
| Progression-free survival of patients managed with SIGNATERA™ ctDNA data | Compare progression-free survival of patients managed with available SIGNATERA™ ctDNA data to historical controls | 2 years | 
| Patient satisfaction of SIGNATERA™ ctDNA on treatment recommendations | Assess patient satisfaction regarding the potential role of SIGNATERA™ ctDNA on treatment recommendations using validated questionnaires | 2 years |