NCT04062032

Metabolomic and Inflammatory Effects of Oral Aspirin (ASA) in Subjects at Risk for Melanoma

Pilot Studies Assessing the Metabolomic and Inflammatory Effects of Oral Aspirin (ASA) in Human Subjects at Risk for Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
DRUG	Aspirin 81 mg	ASA 81mg taken daily
DRUG	Aspirin 325mg	ASA 325mg taken daily

Timeline

• Start date: 2016-09-27
• Primary completion: 2019-02-27
• Completion: 2019-02-27
• First posted: 2019-08-20
• Last updated: 2022-02-18

Locations

1 site across 1 country: United States