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NCT04064034 Clinical Trial

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

Pancreas Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04064034
Other study ID # 19-004658
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2019
Est. completion date October 31, 2020

Study information
Verified date November 2020
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date October 31, 2020
Est. primary completion date October 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 17 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Lateral Flow Assay (LFA)
Test to detect the Quiescin Sulfhydryl Oxidase 1 (QSOX1) protein

Locations
Country Name City State
United States Mayo Clinic in Arizona Scottsdale Arizona

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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