Back to resultsALateral Flow Assay to Detect QSOX1 Peptide in Patients With or at Risk for Pancreatic Cancer
Primary Purpose
Pancreas Cancer, Pancreas Cyst
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lateral Flow Assay (LFA)
Sponsored by
About this trial
This is an interventional diagnostic trial for Pancreas Cancer
Eligibility Criteria
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.
Sites / Locations
- Mayo Clinic in Arizona
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Subjects with pancreas cancer
Subjects with non-cancerous disorders
Subjects with pancreas cyst
Arm Description
Subjects will have blood collected and tested for Quiescin Sulfhydryl Oxidase 1 (QSOX1) protein with the lateral flow assay (LFA).
Subjects will have blood collected and tested for Quiescin Sulfhydryl Oxidase 1 (QSOX1) protein with the lateral flow assay (LFA).
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).
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04064034
Brief Title
ALateral Flow Assay to Detect QSOX1 Peptide in Patients With or at Risk for Pancreatic Cancer
Official Title
Evaluation of the Diagnostic Potential a Lateral Flow Assay to Detect QSOX1 Peptide in Patients With or at Risk for Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
October 31, 2020 (Actual)
Study Completion Date
October 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreas Cancer, Pancreas Cyst
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subjects with pancreas cancer
Arm Type
Experimental
Arm Description
Subjects will have blood collected and tested for Quiescin Sulfhydryl Oxidase 1 (QSOX1) protein with the lateral flow assay (LFA).
Arm Title
Subjects with non-cancerous disorders
Arm Type
Experimental
Arm Description
Subjects will have blood collected and tested for Quiescin Sulfhydryl Oxidase 1 (QSOX1) protein with the lateral flow assay (LFA).
Arm Title
Subjects with pancreas cyst
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Lateral Flow Assay (LFA)
Intervention Description
Test to detect the Quiescin Sulfhydryl Oxidase 1 (QSOX1) protein
Primary Outcome Measure Information:
Title
Quiescin Sulfhydryl Oxidase 1 (QSOX1) in the blood
Description
Number of subjects with the presence and concentration of QSOX1 peptide found in the blood samples by the lateral flow assay (LFA) test
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas Faigel, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
ALateral Flow Assay to Detect QSOX1 Peptide in Patients With or at Risk for Pancreatic Cancer
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