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


2019-08-01


2020-10-31


2020-10-31


60

Study Overview

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

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.

N/A

  • Pancreas Cancer
  • Pancreas Cyst
  • OTHER: Lateral Flow Assay (LFA)
  • 19-004658

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2019-08-19  

N/A  

2020-11-30  

2019-08-19  

N/A  

2020-12-02  

2019-08-21  

N/A  

2020-11  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Diagnostic


Allocation:
Non Randomized


Interventional Model:
Parallel


Masking:
None


Arms and Interventions

Participant Group/ArmIntervention/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
Primary Outcome MeasuresMeasure DescriptionTime Frame
Quiescin Sulfhydryl Oxidase 1 (QSOX1) in the bloodNumber of subjects with the presence and concentration of QSOX1 peptide found in the blood samples by the lateral flow assay (LFA) testBaseline
Secondary Outcome MeasuresMeasure DescriptionTime Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
17 Years

Accepts Healthy Volunteers:
1

    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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.


    • PRINCIPAL_INVESTIGATOR: Douglas Faigel, MD, Mayo Clinic

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available