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:
University of Utah
Organization:
Study Overview
Official Title:
Pilot Studies Assessing the Metabolomic and Inflammatory Effects of Oral Aspirin (ASA) in Human Subjects at Risk for Melanoma
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: