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Trial record 1 of 1 for:    qsox1
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ALateral Flow Assay to Detect QSOX1 Peptide in Patients With or at Risk for Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT04064034
Recruitment Status : Completed
First Posted : August 21, 2019
Last Update Posted : December 2, 2020
Sponsor:
Information provided by (Responsible Party):
Douglas O. Faigel, Mayo Clinic

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pancreas Cancer Pancreas Cyst Other: Lateral Flow Assay (LFA) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of the Diagnostic Potential a Lateral Flow Assay to Detect QSOX1 Peptide in Patients With or at Risk for Pancreatic Cancer
Actual Study Start Date : August 1, 2019
Actual Primary Completion Date : October 31, 2020
Actual Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Subjects with pancreas cancer
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)
Test to detect the Quiescin Sulfhydryl Oxidase 1 (QSOX1) protein
Experimental: Subjects with non-cancerous disorders
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)
Test to detect the Quiescin Sulfhydryl Oxidase 1 (QSOX1) protein
Experimental: Subjects with pancreas cyst
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)
Test to detect the Quiescin Sulfhydryl Oxidase 1 (QSOX1) protein


Outcome Measures
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Primary Outcome Measures :
  1. Quiescin Sulfhydryl Oxidase 1 (QSOX1) in the blood [ Time Frame: Baseline ]
    Number of subjects with the presence and concentration of QSOX1 peptide found in the blood samples by the lateral flow assay (LFA) test


Eligibility Criteria
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Ages Eligible for Study:   17 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04064034


Locations
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United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Douglas Faigel, MD Mayo Clinic
More Information
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Additional Information:

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Responsible Party: Douglas O. Faigel, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04064034    
Other Study ID Numbers: 19-004658
First Posted: August 21, 2019    Key Record Dates
Last Update Posted: December 2, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Pancreatic Cyst
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Cysts