Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-25 @ 7:13 PM
Study NCT ID:
NCT04062032
Status:
COMPLETED
Last Update Posted:
2022-02-18
First Post:
2019-08-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Metabolomic and Inflammatory Effects of Oral Aspirin (ASA) in Subjects at Risk for Melanoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008545', 'term': 'Melanoma'}], 'ancestors': [{'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001241', 'term': 'Aspirin'}], 'ancestors': [{'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-16', 'studyFirstSubmitDate': '2019-08-13', 'studyFirstSubmitQcDate': '2019-08-18', 'lastUpdatePostDateStruct': {'date': '2022-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in concentration of ASA metabolites (salicylate and salicylurate) in plasma after ASA ingestion', 'timeFrame': 'Change from baseline to day 7', 'description': 'Concentration (ng/mL) of pre-treatment ASA metabolites (salicylate and salicylurate) in plasma will be compared to the concentration of ASA metabolites at day 7'}, {'measure': 'Change in concentration of ASA metabolites in nevus tissue after ASA ingestion', 'timeFrame': 'Change from baseline to day 7', 'description': 'Pre-treatment ASA metabolites in tissue will be compared to ASA metabolites at day 7'}, {'measure': 'Change in concentration of prostaglandin E2 (PGE2) in plasma after ASA ingestion', 'timeFrame': 'Change from baseline to day 7', 'description': 'Baseline PGE2 levels in plasma specimens will be compared to PGE2 levels at day 7.'}, {'measure': 'Change in concentration of prostaglandin E2 (PGE2) in nevus tissue after ASA ingestion', 'timeFrame': 'Change from baseline to day 7', 'description': 'Baseline PGE2 levels in tissue specimens will be compared to PGE2 levels at day 7.'}], 'secondaryOutcomes': [{'measure': 'Change in AMP-activated protein kinase (AMPK) activation in nevi after ASA ingestion', 'timeFrame': 'Change from baseline to day 7', 'description': 'Quantitative densitometry analysis using Western blots will be performed on tissue collected at baseline and at day 7 to compare activation of AMP-activated protein kinase (AMPK).'}, {'measure': 'Change in concentration of leukocytes in peripheral blood after ASA ingestion', 'timeFrame': 'Change from baseline to day 7', 'description': 'Whole blood will be taken at baseline and at day 7 to compare concentration of leukocytes'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Melanoma (Skin)']}, 'descriptionModule': {'briefSummary': 'This is an open label phase II pilot study assessing the metabolomic and inflammatory effects of oral aspirin (ASA) in human subjects at risk for melanoma.', 'detailedDescription': 'Primary Objectives\n\nI. Open label trial in 60 patients to assess the capacity of either of one daily dose (81, 325 mg) of sub-chronic ASA administration to increase the plasma and nevus ASA metabolites such as: salicylate, salicylurate, gentisic acid, and salicyl acyl glucuronide.\n\nII. Open label trial in 60 patients to assess the capacity of sub-chronic daily ASA (81, 325 mg) administration to reduce levels of prostaglandin E2 (PGE2) in plasma and nevi.\n\nSecondary Objectives\n\nI. Determine whether ASA increases AMP-activated protein kinase (AMPK) activation in nevi.\n\nII. Determine whether ASA affects whole blood leukocytes or leukocyte subsets in plasma.\n\nIII. Determine whether ASA affects inflammatory cytokines in plasma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have at least 2 nevi (each \\>5 mm diameter) not clinically suspicious for melanoma that can be biopsied.\n* Must be older than age 18.\n* Must be able to receive informed consent and sign an approved consent form that conforms to federal and institutional guidelines.\n\nExclusion Criteria:\n\n* The patient is a minor, under age 18.\n* The patient cannot speak / understand English or Spanish.\n* The patient is pregnant or breastfeeding.\n* The patient is a prisoner, critically or mentally ill, or otherwise incapacitated or considered vulnerable.\n* The patient has history of allergic reaction to ASA.\n* The patient has history of severe asthma.\n* The patient has been taking ASA or any NSAID in the past 2 weeks.\n* The patient has been taking a blood thinner in the past 2 weeks.\n* The patient has history of bleeding disorder.\n* The patient has history of peptic ulcer disease.\n* The patient has had recent intense UV exposure in the past month.'}, 'identificationModule': {'nctId': 'NCT04062032', 'briefTitle': 'Metabolomic and Inflammatory Effects of Oral Aspirin (ASA) in Subjects at Risk for Melanoma', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'Pilot Studies Assessing the Metabolomic and Inflammatory Effects of Oral Aspirin (ASA) in Human Subjects at Risk for Melanoma', 'orgStudyIdInfo': {'id': 'HCI94424 Pilot'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ASA 81 mg daily', 'description': 'Participants will be given ASA 81 mg orally once daily for a total of 7 days', 'interventionNames': ['Drug: Aspirin 81 mg']}, {'type': 'EXPERIMENTAL', 'label': 'ASA 325 mg daily', 'description': 'Participants will be given ASA 325 mg orally once daily for a total of 7 days.', 'interventionNames': ['Drug: Aspirin 325mg']}], 'interventions': [{'name': 'Aspirin 81 mg', 'type': 'DRUG', 'otherNames': ['ASA'], 'description': 'ASA 81mg taken daily', 'armGroupLabels': ['ASA 81 mg daily']}, {'name': 'Aspirin 325mg', 'type': 'DRUG', 'otherNames': ['ASA'], 'description': 'ASA 325mg taken daily', 'armGroupLabels': ['ASA 325 mg daily']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Huntsman Cancer Institute/University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Douglas Grossman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Huntsman Cancer Institute/ University of Utah'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}