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

NCT04062032 | Completed Phase 2 DMC

• 1 other identifier: HCI94424 Pilot
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Melanoma (Skin)

Outcome Measures

Primary Outcomes (4)

• 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 from baseline to 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 from baseline to 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 from baseline to 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.

  Change from baseline to day 7

Secondary Outcomes (2)

• Change in AMP-activated protein kinase (AMPK) activation in nevi after ASA ingestion

  Change from baseline to day 7

• Change in concentration of leukocytes in peripheral blood after ASA ingestion

  Change from baseline to day 7

Study Arms (2)

ASA 81 mg daily

EXPERIMENTAL

Participants will be given ASA 81 mg orally once daily for a total of 7 days

Drug: Aspirin 81 mg

ASA 325 mg daily

EXPERIMENTAL

Participants will be given ASA 325 mg orally once daily for a total of 7 days.

Drug: Aspirin 325mg

Interventions

Aspirin 81 mg DRUG

ASA 81mg taken daily

Also known as: ASA

ASA 81 mg daily

Aspirin 325mg DRUG

ASA 325mg taken daily

Also known as: ASA

ASA 325 mg daily

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Douglas Grossman, MD

  Huntsman Cancer Institute/ University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2019
• First Posted: August 20, 2019
• Study Start: September 27, 2016
• Primary Completion: February 27, 2019
• Study Completion: February 27, 2019
• Last Updated: February 18, 2022

Record last verified: 2022-02

Locations

US (1)