Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-31 @ 10:17 PM
Study NCT ID:
NCT04064034
Status:
COMPLETED
Last Update Posted:
2020-12-02
First Post:
2019-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ALateral Flow Assay to Detect QSOX1 Peptide in Patients With or at Risk for Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D010181', 'term': 'Pancreatic Cyst'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003560', 'term': 'Cysts'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-30', 'studyFirstSubmitDate': '2019-08-19', 'studyFirstSubmitQcDate': '2019-08-19', 'lastUpdatePostDateStruct': {'date': '2020-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quiescin Sulfhydryl Oxidase 1 (QSOX1) in the blood', 'timeFrame': 'Baseline', 'description': 'Number of subjects with the presence and concentration of QSOX1 peptide found in the blood samples by the lateral flow assay (LFA) test'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pancreas Cancer', 'Pancreas Cyst']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '17 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients with biopsy-proven adenocarcinoma prior to receiving any therapy such as surgery, radiation or chemotherapy.\n* Patients without pancreas cancer.\n* Adult patients with benign pancreas disorders such as pancreatitis with imaging within 12 months (CT, MRI, EUS) documenting no cancer.\n* Healthy adults with blood specimens in an existing biobank.\n* Patients with pancreatic cystic lesions.\n* Adult patients undergoing clinically indicated EUS-guided FNA biopsy of pancreatic cystic lesions.\n\nExclusion Criteria:\n\n* Prior treatment for pancreas cancer.\n* Unable or unwilling to give consent.'}, 'identificationModule': {'nctId': 'NCT04064034', 'briefTitle': 'ALateral Flow Assay to Detect QSOX1 Peptide in Patients With or at Risk for Pancreatic Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Evaluation of the Diagnostic Potential a Lateral Flow Assay to Detect QSOX1 Peptide in Patients With or at Risk for Pancreatic Cancer', 'orgStudyIdInfo': {'id': '19-004658'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Subjects with pancreas cancer', 'description': 'Subjects will have blood collected and tested for Quiescin Sulfhydryl Oxidase 1 (QSOX1) protein with the lateral flow assay (LFA).', 'interventionNames': ['Other: Lateral Flow Assay (LFA)']}, {'type': 'EXPERIMENTAL', 'label': 'Subjects with non-cancerous disorders', 'description': 'Subjects will have blood collected and tested for Quiescin Sulfhydryl Oxidase 1 (QSOX1) protein with the lateral flow assay (LFA).', 'interventionNames': ['Other: Lateral Flow Assay (LFA)']}, {'type': 'EXPERIMENTAL', 'label': 'Subjects with pancreas cyst', '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).', 'interventionNames': ['Other: Lateral Flow Assay (LFA)']}], 'interventions': [{'name': 'Lateral Flow Assay (LFA)', 'type': 'OTHER', 'description': 'Test to detect the Quiescin Sulfhydryl Oxidase 1 (QSOX1) protein', 'armGroupLabels': ['Subjects with non-cancerous disorders', 'Subjects with pancreas cancer', 'Subjects with pancreas cyst']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic in Arizona', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}], 'overallOfficials': [{'name': 'Douglas Faigel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Douglas O. Faigel', 'investigatorAffiliation': 'Mayo Clinic'}}}}