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

Not Applicable

Completed

• Conditions: Pancreas Cancer; Pancreas Cyst
• Interventions: Other: Lateral Flow Assay (LFA)

• Registration Number: NCT04064034
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-01
• Study First Submitted: 2019-08-19
• Study First Submitted QC: 2019-08-19
• Study First Posted: 2019-08-21
• Primary Completion: 2020-10-31
• Study Completion: 2020-10-31
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-30
• Last Update Posted: 2020-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Subjects with non-cancerous disorders	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 with pancreas cancer	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 with pancreas cyst	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).

Primary Outcome Measures

Name	Time	Method
Quiescin Sulfhydryl Oxidase 1 (QSOX1) in the blood	Baseline	Number of subjects with the presence and concentration of QSOX1 peptide found in the blood samples by the lateral flow assay (LFA) test

Trial Locations

Locations (1)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States