ALateral Flow Assay to Detect QSOX1 Peptide in Patients With or at Risk for Pancreatic Cancer
Evaluation of the Diagnostic Potential a Lateral Flow Assay to Detect QSOX1 Peptide in Patients With or at Risk for Pancreatic Cancer
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2019
CompletedFirst Submitted
Initial submission to the registry
August 19, 2019
CompletedFirst Posted
Study publicly available on registry
August 21, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2020
CompletedDecember 2, 2020
November 1, 2020
1.3 years
August 19, 2019
November 30, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
Subjects with pancreas cancer
EXPERIMENTALSubjects will have blood collected and tested for Quiescin Sulfhydryl Oxidase 1 (QSOX1) protein with the lateral flow assay (LFA).
Subjects with non-cancerous disorders
EXPERIMENTALSubjects will have blood collected and tested for Quiescin Sulfhydryl Oxidase 1 (QSOX1) protein with the lateral flow assay (LFA).
Subjects with pancreas cyst
EXPERIMENTALSubjects 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).
Interventions
Test to detect the Quiescin Sulfhydryl Oxidase 1 (QSOX1) protein
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Prior treatment for pancreas cancer.
- Unable or unwilling to give consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Douglas Faigel, MD
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 19, 2019
First Posted
August 21, 2019
Study Start
August 1, 2019
Primary Completion
October 31, 2020
Study Completion
October 31, 2020
Last Updated
December 2, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share