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

NCT ID: NCT04064034

Last Updated: 2020-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2020-10-31

Brief Summary

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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

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Conditions

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Pancreas Cancer Pancreas Cyst

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Subjects with pancreas cancer

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

Group Type EXPERIMENTAL

Lateral Flow Assay (LFA)

Intervention Type OTHER

Test to detect the Quiescin Sulfhydryl Oxidase 1 (QSOX1) protein

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).

Group Type EXPERIMENTAL

Lateral Flow Assay (LFA)

Intervention Type OTHER

Test to detect the Quiescin Sulfhydryl Oxidase 1 (QSOX1) protein

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).

Group Type EXPERIMENTAL

Lateral Flow Assay (LFA)

Intervention Type OTHER

Test to detect the Quiescin Sulfhydryl Oxidase 1 (QSOX1) protein

Interventions

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Lateral Flow Assay (LFA)

Test to detect the Quiescin Sulfhydryl Oxidase 1 (QSOX1) protein

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Douglas O. Faigel

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Douglas Faigel, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Site Status

Countries

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United States

Related Links

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https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

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19-004658

Identifier Type: -

Identifier Source: org_study_id