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

Mayo Clinic

Status: Completed

Conditions: Pancreas Cancer; Pancreas Cyst

Treatments: Other: Lateral Flow Assay (LFA)

Study type: Interventional

Funder types: Other

Identifiers

NCT04064034

19-004658

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 17+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Subjects with pancreas cancer

Experimental group

Description:

Subjects will have blood collected and tested for Quiescin Sulfhydryl Oxidase 1 (QSOX1) protein with the lateral flow assay (LFA).

Treatment:

Other: Lateral Flow Assay (LFA)

Subjects with non-cancerous disorders

Experimental group

Description:

Subjects will have blood collected and tested for Quiescin Sulfhydryl Oxidase 1 (QSOX1) protein with the lateral flow assay (LFA).

Treatment:

Other: Lateral Flow Assay (LFA)

Subjects with pancreas cyst

Experimental group

Description:

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).

Treatment:

Other: Lateral Flow Assay (LFA)