Model of diseAses Related to Environmental Exposure to Heavy meTals, nanopaRticles and Emergent Contaminants, Using a dIgital platfOrm of Clinical and Bio-humoral Data: the Way to Susceptibility/RisK BiomArker [MATRIOSKA Study] - The Seed.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 280
- 试验地点
- 2
- 主要终点
- Serum concentration of metals
研究概览
简要总结
The goal of this clinical trial is to collect environmental, bio-humoral, and clinical data derived from patients with allergic contact dermatitis (ACD) and systemic metal allergic syndromes related to the exposure to heavy metals, nanoparticles, and emergent contaminants and from healthy subjects.
The main question it aims to answer is: are environmental, bio-humoral, and clinical data derived from patients with ACD and systemic metal allergic syndromes, related to the exposure to heavy metals, nanoparticles, and emergent contaminants, different from ones obtained by healthy subjects? Researchers will compare serum and urine concentration of heavy metals and nanoparticles, patch test to metals, within-breath analysis of oscillometry parameters, serum zonulin, and serum levels of protein oxidation products among patients with systemic allergic syndrome (1st study group), patients with ACD (2nd study group) and healthy subjects (3rd study group).
Participants will undergo:
- measurement of exposure to heavy metals and nanoparticles including nickel, cobalt, chromium, palladium, molybdenum, aluminium, and copper, through serum and urine measurement of concentration.
- Patch test to before mentioned metals.
- Within-breath analysis of oscillometry parameters.
- Measurement of serum zonulin (related to gastro-intestinal exposure).
- Measurement of serum levels of protein oxidation products (as markers of systemic oxidative stress).
详细描述
Heavy metals [nickel (Ni), cobalt (Co), chromium (Cr), palladium, molybdenum, aluminium, and copper] are environmental contaminants able to impact on host cells of humans and various organisms, potentially causing serious damage. These metals can be present also in form of nanoparticles.
Nanoparticles are tiny particles between 1 and 100 nanometres in size. Nanoparticles have applications in a wide range of fields, including medicine, electronics, energy, and environmental remediation. However, the potential environmental and health risks associated with nanoparticles are also focus of global research.
The research on metal allergies in exposed subjects is challenging since the exposures are common both at the workplace and outside.
Environmental exposures are important for development of allergic contact dermatitis (ACD).
ACD is a common skin disorder caused by contact with an exogenous substance that elicits a hypersensitivity response in susceptible individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •adult subjects (over 18 years of age).
- •Subjects suffering from allergic contact dermatitis due to metals.
- •Subjects with systemic allergic syndrome due to metals.
- •Adult healthy subjects.
- •Subjects able to give written informed consent.
排除标准
- •Subjects under the age of 18years.
- •Pregnant/breastfeeding women.
- •Subjects suffering from chronic renal failure requiring replacement treatment.
- •Subjects suffering from other systemic pathologies related to exposure to metals.
- •Subjects suffering from gastrointestinal diseases such as celiac disease, chronic inflammatory intestinal diseases, tumors, other skin diseases.
- •Subjects unable to express written informed consent.
研究组 & 干预措施
Allergic contact dermatitis to metals
Patients with allergic contact dermatitis due to metal exposure (nickel, cobalt, chromium, palladium, molybdenum, aluminium, and copper).
干预措施: Collection of environmental, biological, and clinical data (Diagnostic Test)
Systemic allergic syndromes to metals
Patients with systemic allergic syndrome due to metal exposure (nickel, cobalt, chromium, palladium, molybdenum, aluminium, and copper).
干预措施: Collection of environmental, biological, and clinical data (Diagnostic Test)
Healthy volunteers
Healthy volunteers without metal exposure (nickel, cobalt, chromium, palladium, molybdenum, aluminium, and copper).
干预措施: Collection of environmental, biological, and clinical data (Diagnostic Test)
结局指标
主要结局
Serum concentration of metals
时间窗: At enrollment.
Measurement of serum concentration of heavy metals and nanoparticles including nickel, cobalt, chromium, palladium, molybdenum, aluminium, and copper.
Urinary concentration of metals
时间窗: At enrollment.
Measurement of urinary concentration of heavy metals and nanoparticles including nickel, cobalt, chromium, palladium, molybdenum, aluminium, and copper.
Serum concentration of protein oxidation products
时间窗: At enrollment.
Measurement of serum protein oxidation products as markers of systemic oxidative stress.
Number of subjects with altered values of respiratory system impedance
时间窗: At enrollment.
All patients and healthy volunteers will undergo oscillometry. Tidal breathing analysis with impulse oscillometry (IOS) has proven to be an informative and meaningful tool to characterize peripheral airways dysfunction.
Serum concentration of zonulin
时间窗: At enrollment.
Measurement of serum zonulin.
Patch test
时间窗: At enrollment.
Application of patch test with heavy metals including nickel, cobalt, chromium, palladium, molybdenum, aluminium, and copper. Patch tests will be evaluated 48h and 72h after their application and will be evaluated through a universally accepted grading system elaborated by The International Contact Dermatitis Research Group. The intensity will be assessed according to the following criteria: 1. ± faint, non-palpable erythema; 2. \+ palpable erythema; 3. ++ strong infiltrate, numerous papules, and vesicles present strong reaction; 4. +++ coalescing vesicles, bullae or ulceration, and an extreme erythematous reaction.
次要结局
未报告次要终点