Back to resultsMetabolomic and Inflammatory Effects of Oral Aspirin (ASA) in Subjects at Risk for Melanoma
Primary Purpose
Melanoma (Skin)
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Aspirin 81 mg
Aspirin 325mg
Sponsored by
About this trial
This is an interventional prevention trial for Melanoma (Skin)
Eligibility Criteria
Inclusion Criteria:
- Must have at least 2 nevi (each >5 mm diameter) not clinically suspicious for melanoma that can be biopsied.
- Must be older than age 18.
- Must be able to receive informed consent and sign an approved consent form that conforms to federal and institutional guidelines.
Exclusion Criteria:
- The patient is a minor, under age 18.
- The patient cannot speak / understand English or Spanish.
- The patient is pregnant or breastfeeding.
- The patient is a prisoner, critically or mentally ill, or otherwise incapacitated or considered vulnerable.
- The patient has history of allergic reaction to ASA.
- The patient has history of severe asthma.
- The patient has been taking ASA or any NSAID in the past 2 weeks.
- The patient has been taking a blood thinner in the past 2 weeks.
- The patient has history of bleeding disorder.
- The patient has history of peptic ulcer disease.
- The patient has had recent intense UV exposure in the past month.
Sites / Locations
- Huntsman Cancer Institute/University of Utah
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
ASA 81 mg daily
ASA 325 mg daily
Arm Description
Participants will be given ASA 81 mg orally once daily for a total of 7 days
Participants will be given ASA 325 mg orally once daily for a total of 7 days.
Outcomes
Primary Outcome Measures
Change in concentration of ASA metabolites (salicylate and salicylurate) in plasma after ASA ingestion
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
Change in concentration of ASA metabolites in nevus tissue after ASA ingestion
Pre-treatment ASA metabolites in tissue will be compared to ASA metabolites at day 7
Change in concentration of prostaglandin E2 (PGE2) in plasma after ASA ingestion
Baseline PGE2 levels in plasma specimens will be compared to PGE2 levels at day 7.
Change in concentration of prostaglandin E2 (PGE2) in nevus tissue after ASA ingestion
Baseline PGE2 levels in tissue specimens will be compared to PGE2 levels at day 7.
Secondary Outcome Measures
Change in AMP-activated protein kinase (AMPK) activation in nevi after ASA ingestion
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).
Change in concentration of leukocytes in peripheral blood after ASA ingestion
Whole blood will be taken at baseline and at day 7 to compare concentration of leukocytes
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04062032
Brief Title
Metabolomic and Inflammatory Effects of Oral Aspirin (ASA) in Subjects at Risk for Melanoma
Official Title
Pilot Studies Assessing the Metabolomic and Inflammatory Effects of Oral Aspirin (ASA) in Human Subjects at Risk for Melanoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
September 27, 2016 (Actual)
Primary Completion Date
February 27, 2019 (Actual)
Study Completion Date
February 27, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Utah
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
Primary Objectives
I. 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.
II. 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.
Secondary Objectives
I. Determine whether ASA increases AMP-activated protein kinase (AMPK) activation in nevi.
II. Determine whether ASA affects whole blood leukocytes or leukocyte subsets in plasma.
III. Determine whether ASA affects inflammatory cytokines in plasma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin)
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ASA 81 mg daily
Arm Type
Experimental
Arm Description
Participants will be given ASA 81 mg orally once daily for a total of 7 days
Arm Title
ASA 325 mg daily
Arm Type
Experimental
Arm Description
Participants will be given ASA 325 mg orally once daily for a total of 7 days.
Intervention Type
Drug
Intervention Name(s)
Aspirin 81 mg
Other Intervention Name(s)
ASA
Intervention Description
ASA 81mg taken daily
Intervention Type
Drug
Intervention Name(s)
Aspirin 325mg
Other Intervention Name(s)
ASA
Intervention Description
ASA 325mg taken daily
Primary Outcome Measure Information:
Title
Change in concentration of ASA metabolites (salicylate and salicylurate) in plasma after ASA ingestion
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
Time Frame
Change from baseline to day 7
Title
Change in concentration of ASA metabolites in nevus tissue after ASA ingestion
Description
Pre-treatment ASA metabolites in tissue will be compared to ASA metabolites at day 7
Time Frame
Change from baseline to day 7
Title
Change in concentration of prostaglandin E2 (PGE2) in plasma after ASA ingestion
Description
Baseline PGE2 levels in plasma specimens will be compared to PGE2 levels at day 7.
Time Frame
Change from baseline to day 7
Title
Change in concentration of prostaglandin E2 (PGE2) in nevus tissue after ASA ingestion
Description
Baseline PGE2 levels in tissue specimens will be compared to PGE2 levels at day 7.
Time Frame
Change from baseline to day 7
Secondary Outcome Measure Information:
Title
Change in AMP-activated protein kinase (AMPK) activation in nevi after ASA ingestion
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).
Time Frame
Change from baseline to day 7
Title
Change in concentration of leukocytes in peripheral blood after ASA ingestion
Description
Whole blood will be taken at baseline and at day 7 to compare concentration of leukocytes
Time Frame
Change from baseline to day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Must have at least 2 nevi (each >5 mm diameter) not clinically suspicious for melanoma that can be biopsied.
Must be older than age 18.
Must be able to receive informed consent and sign an approved consent form that conforms to federal and institutional guidelines.
Exclusion Criteria:
The patient is a minor, under age 18.
The patient cannot speak / understand English or Spanish.
The patient is pregnant or breastfeeding.
The patient is a prisoner, critically or mentally ill, or otherwise incapacitated or considered vulnerable.
The patient has history of allergic reaction to ASA.
The patient has history of severe asthma.
The patient has been taking ASA or any NSAID in the past 2 weeks.
The patient has been taking a blood thinner in the past 2 weeks.
The patient has history of bleeding disorder.
The patient has history of peptic ulcer disease.
The patient has had recent intense UV exposure in the past month.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas Grossman, MD
Organizational Affiliation
Huntsman Cancer Institute/ University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
Huntsman Cancer Institute/University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Metabolomic and Inflammatory Effects of Oral Aspirin (ASA) in Subjects at Risk for Melanoma
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