Clinical trial · Interventional
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
NCT04062032CI-TRIAL-00056603completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ASA 81 mg daily
- description
- Participants will be given ASA 81 mg orally once daily for a total of 7 days
- interventionNames
- Drug: Aspirin 81 mg
- type
- EXPERIMENTAL
- label
- ASA 325 mg daily
- description
- Participants will be given ASA 325 mg orally once daily for a total of 7 days.
- interventionNames
- Drug: Aspirin 325mg
Primary outcomes (4)
- measure
- Change in concentration of ASA metabolites (salicylate and salicylurate) in plasma after ASA ingestion
- timeFrame
- Change from baseline to day 7
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.