Status:
COMPLETED
Metabolomic and Inflammatory Effects of Oral Aspirin (ASA) in Subjects at Risk for Melanoma
Lead Sponsor:
University of Utah
Conditions:
Melanoma (Skin)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 metabolite...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 27 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 27 2019
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT04062032
Start Date
September 27 2016
End Date
February 27 2019
Last Update
February 18 2022
Active Locations (1)
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1
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112