Melanoma (Skin)Phase 2NCT04062032
Metabolomic and Inflammatory Effects of Oral Aspirin (ASA) in Subjects at Risk for Melanoma
A Phase 2 study testing Aspirin 81 mg and Aspirin 325mg in people with Melanoma (Skin), run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Melanoma (Skin)
- What is being tested?
- Aspirin 81 mg and Aspirin 325mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2016to 27 Feb 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
About this study
Official title: Pilot Studies Assessing the Metabolomic and Inflammatory Effects of Oral Aspirin (ASA) in Human Subjects at Risk for Melanoma
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.
Read the detailed description
Primary Objectives
- 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
- 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)
- Being tested
- Aspirin 81 mg, Aspirin 325mg
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin 81 mgDrug
Also called ASA
ASA 81mg taken daily
Aspirin 325mgDrug
Also called ASA
ASA 325mg taken daily
| Study group | Role | What they receive |
|---|---|---|
| ASA 81 mg daily | Experimental | Participants will be given ASA 81 mg orally once daily for a total of 7 days Receives: 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. Receives: Drug: Aspirin 325mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Change from baseline to day 7
Secondary outcomes (2)
Change in AMP-activated protein kinase (AMPK) activation in nevi after ASA ingestion
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).
Measured: Change from baseline to day 7
Change in concentration of leukocytes in peripheral blood after ASA ingestion
Whole blood will be taken at baseline and at day 7 to compare concentration of leukocytes
Measured: Change from baseline to day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start27 Sep 2016
- Primary completion27 Feb 2019
- Study completion27 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin)Studies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Douglas Grossman, MD, Principal investigator, Huntsman Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04062032
- Sponsor's protocol ID
- HCI94424 Pilot
- Status last verified
- Feb 2022
- First submitted
- 13 Aug 2019
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Studies Assessing the Metabolomic and Inflammatory Effects of Oral Aspirin (ASA) in Human Subjects at Risk for Melanoma
- ClinicalTrials.gov ID
- NCT04062032
- Acronym / sponsor ID
- HCI94424 Pilot
- Conditions
- Melanoma (Skin)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 27 Sep 2016 (actual)
- Primary completion
- 27 Feb 2019 (actual)
- Study completion
- 27 Feb 2019 (actual)
- First posted
- 20 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
- 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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASA 81 mg daily | Experimental | Drug: Aspirin 81 mgParticipants will be given ASA 81 mg orally once daily for a total of 7 days |
| ASA 325 mg daily | Experimental | Drug: Aspirin 325mgParticipants will be given ASA 325 mg orally once daily for a total of 7 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aspirin 81 mgAlso: ASAASA 81mg taken daily | Drug | ASA 81 mg daily |
| Aspirin 325mgAlso: ASAASA 325mg taken daily | Drug | ASA 325 mg daily |
Primary outcome
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
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
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.
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.
2 secondary outcomes
Change in AMP-activated protein kinase (AMPK) activation in nevi after ASA ingestion
Time frame: Change from baseline to day 7
Change in concentration of leukocytes in peripheral blood after ASA ingestion
Time frame: Change from baseline to day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas Grossman, MD principal investigator
Huntsman Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aspirin 81 mg and Aspirin 325mg in people with Melanoma (Skin), run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in concentration of ASA metabolites (salicylate and salicylurate) in plasma after ASA ingestion (time frame: Change from baseline to day 7). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2022.