Pilot Studies Assessing the Metabolomic and Inflammatory Effects of Oral Aspirin (ASA) in Human Subjects at Risk for Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Change in concentration of ASA metabolites (salicylate and salicylurate) in plasma after ASA ingestion
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must have at least 2 nevi (each >5 mm diameter) not clinically suspicious for melanoma that can be biopsied.
- •Must be older than age
- •Must be able to receive informed consent and sign an approved consent form that conforms to federal and institutional guidelines.
排除标准
- •The patient is a minor, under age
- •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.
研究组 & 干预措施
ASA 81 mg daily
Participants will be given ASA 81 mg orally once daily for a total of 7 days
干预措施: Aspirin 81 mg (Drug)
ASA 325 mg daily
Participants will be given ASA 325 mg orally once daily for a total of 7 days.
干预措施: Aspirin 325mg (Drug)
结局指标
主要结局
Change in concentration of ASA metabolites (salicylate and salicylurate) in plasma after ASA ingestion
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Change from baseline to day 7
Baseline PGE2 levels in tissue specimens will be compared to PGE2 levels at day 7.
次要结局
- Change in concentration of leukocytes in peripheral blood after ASA ingestion(Change from baseline to day 7)
- Change in AMP-activated protein kinase (AMPK) activation in nevi after ASA ingestion(Change from baseline to day 7)