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

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ClinicalTrials.gov Identifier: NCT04062032
Recruitment Status : Recruiting
First Posted : August 20, 2019
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
University of Utah

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.

Condition or disease Intervention/treatment Phase
Melanoma (Skin) Drug: Aspirin 81 mg Drug: Aspirin 325mg Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pilot Studies Assessing the Metabolomic and Inflammatory Effects of Oral Aspirin (ASA) in Human Subjects at Risk for Melanoma
Actual Study Start Date : September 27, 2016
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: ASA 81 mg daily
Participants will be given ASA 81 mg orally once daily for a total of 7 days
Drug: Aspirin 81 mg
ASA 81mg taken daily
Other Name: ASA

Experimental: ASA 325 mg daily
Participants will be given ASA 325 mg orally once daily for a total of 7 days.
Drug: Aspirin 325mg
ASA 325mg taken daily
Other Name: ASA




Primary Outcome Measures :
  1. Change in concentration of ASA metabolites (salicylate and salicylurate) in plasma after ASA ingestion [ Time Frame: Change from baseline to day 7 ]
    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

  2. Change in concentration of ASA metabolites in nevus tissue after ASA ingestion [ Time Frame: Change from baseline to day 7 ]
    Pre-treatment ASA metabolites in tissue will be compared to ASA metabolites at day 7

  3. Change in concentration of prostaglandin E2 (PGE2) in plasma after ASA ingestion [ Time Frame: Change from baseline to day 7 ]
    Baseline PGE2 levels in plasma specimens will be compared to PGE2 levels at day 7.

  4. Change in concentration of prostaglandin E2 (PGE2) in nevus tissue after ASA ingestion [ Time Frame: Change from baseline to day 7 ]
    Baseline PGE2 levels in tissue specimens will be compared to PGE2 levels at day 7.


Secondary Outcome Measures :
  1. Change in AMP-activated protein kinase (AMPK) activation in nevi after ASA ingestion [ Time Frame: Change from baseline to day 7 ]
    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).

  2. Change in concentration of leukocytes in peripheral blood after ASA ingestion [ Time Frame: Change from baseline to day 7 ]
    Whole blood will be taken at baseline and at day 7 to compare concentration of leukocytes



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04062032


Contacts
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Contact: Douglas Grossman, MD 801-581-4682 doug.grossman@hci.utah.edu

Locations
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United States, Utah
Huntsman Cancer Institute/University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Douglas Grossman, MD    801-581-4682    doug.grossman@hci.utah.edu   
Sponsors and Collaborators
University of Utah
Investigators
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Principal Investigator: Douglas Grossman, MD Huntsman Cancer Institute/ University of Utah

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Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT04062032     History of Changes
Other Study ID Numbers: HCI94424 Pilot
First Posted: August 20, 2019    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics