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

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT04064034

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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)	N/A

Study Design

Study Type:

Interventional

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 :

Aug 1, 2019

Actual Primary Completion Date :

Oct 31, 2020

Actual Study Completion Date :

Oct 31, 2020

Arms and Interventions

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

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

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

17 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Arizona	Scottsdale	Arizona	United States	85259

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: Douglas Faigel, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Douglas O. Faigel, Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT04064034

Other Study ID Numbers:

19-004658

First Posted:

Aug 21, 2019

Last Update Posted:

Dec 2, 2020

Last Verified:

Nov 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pancreatic Neoplasms

Pancreatic Cyst

Study Results

No Results Posted as of Dec 2, 2020