ALateral Flow Assay to Detect QSOX1 Peptide in Patients With or at Risk for Pancreatic Cancer

Study Overview
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Brief Summary
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Researchers have developed a new test to measure a protein QSOX1 that is found to be elevated in subjects with pancreas cancer. Researchers are looking to use this test to compare subjects with pancreas cancer and subjects without pancreas cancer to see if this test could be used to diagnosis pancreas cancer.

Official Title
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Evaluation of the Diagnostic Potential a Lateral Flow Assay to Detect QSOX1 Peptide in Patients With or at Risk for Pancreatic Cancer

Conditions
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Pancreas Cancer, Pancreas Cyst

Intervention / Treatment
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* Other: Lateral Flow Assay (LFA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients with biopsy-proven adenocarcinoma prior to receiving any therapy such as surgery, radiation or chemotherapy. Patients without pancreas cancer. Adult patients with benign pancreas disorders such as pancreatitis with imaging within 12 months (CT, MRI, EUS) documenting no cancer. Healthy adults with blood specimens in an existing biobank. Patients with pancreatic cystic lesions. Adult patients undergoing clinically indicated EUS-guided FNA biopsy of pancreatic cystic lesions. Exclusion Criteria: Prior treatment for pancreas cancer. Unable or unwilling to give consent.

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects with pancreas cancer<br>Subjects will have blood collected and tested for Quiescin Sulfhydryl Oxidase 1 (QSOX1) protein with the lateral flow assay (LFA). | Other: Lateral Flow Assay (LFA)<br>* Test to detect the Quiescin Sulfhydryl Oxidase 1 (QSOX1) protein<br>|
| Experimental: Subjects with non-cancerous disorders<br>Subjects will have blood collected and tested for Quiescin Sulfhydryl Oxidase 1 (QSOX1) protein with the lateral flow assay (LFA). | Other: Lateral Flow Assay (LFA)<br>* Test to detect the Quiescin Sulfhydryl Oxidase 1 (QSOX1) protein<br>|
| Experimental: Subjects with pancreas cyst<br>Subjects already undergoing biopsy of a pancreas cyst will have cyst fluid collected and tested for Quiescin Sulfhydryl Oxidase 1 (QSOX1) protein with the lateral flow assay (LFA). | Other: Lateral Flow Assay (LFA)<br>* Test to detect the Quiescin Sulfhydryl Oxidase 1 (QSOX1) protein<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quiescin Sulfhydryl Oxidase 1 (QSOX1) in the blood | Number of subjects with the presence and concentration of QSOX1 peptide found in the blood samples by the lateral flow assay (LFA) test | Baseline |