NCT06026631进行中（未招募）不适用
Lipidomic Characterization in Non-metastatic Breast Cancer Women Undergoing Surgery: a Pilot Study.
Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2023年9月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Correlation lipidome and BMI
研究概览
简要总结
The goal of this clinical trial is to learn about breast cancer lipodome signature in patients waiting for surgery with different Body Mass Index.
The main question it aims to answer are:
- To highlight a specific lipidome molecular signature for breast cancer patients overweight and obese (BMI > 25 Kg/m2) compared with patients of normal weight (BMI<25 kg/m2).
- Evaluate the effect of the pool of biochemical, nutritional and anatomical-pathological data of breast cancer patients and the correlation between molecular profile and body weight.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Age ≥65 years (would affect the functioning of desaturase enzymes that decline with older age).
- •Invasive primary breast cancer or ductal in situ (DCIS) previously treated with chemo- or radiotherapy.
- •Metastasis at diagnosis.
- •Presence of serious intestinal and hepatic pathologies.
- •Presence of diabetes, both insulin-dependent and in hypoglycaemic treatment or other pancreatic disease, thyroid disease in pharmacological treatment.
- •Supplementation with omega-3 based supplements for at least 6 months.
- •Failure to sign the informed consent to participate in the study.
- •Age ≥65 years;
- •Suffering from tumor pathology;
- •BMI ≥25kg/m2;
- •Refusal to sign informed consent to participate in the study.
结局指标
主要结局
Correlation lipidome and BMI
时间窗: First day
Evaluate the correlation between some biomarkers derived from the lipidomic study (e.g. palmitic acid, stearic acid, oleic acid, palmitoleic acid and sapienic acid, arachidonic acid, dihomogammalinolenic acid, EPA, DHA, etc...) according to the BMI class considered.
次要结局
- Correlation lipidome and nutrition/anatomical-pathological(First day)
研究者
Magno Stefano
Head of UOS Breast Integrative Oncology
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
研究点 (1)
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