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
干预措施
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
- •Age <65 years (not to have influence on functioning of desaturase enzymes that decline with older ages).
- •Neoplastic pathology: primary invasive breast cancer or ductal in situ (DCIS) newly diagnosed, in the pre-operative phase and which has not already undergone chemo- or radiotherapy.
- •Absence of serious intestinal and hepatic pathologies, diabetes, both insulin-dependent and in hypoglycaemic treatment or other pancreatic affection, thyroid affections in pharmacological treatment.
- •Absence of supplementation with omega-3 based supplements for at least 6 months.
- •Homogeneous distribution by BMI (1:1 ratio subjects with BMI≥25 and BMI<25, respectively).
- •Informed consent to participate in the study.
- •Age <65 years;
- •Not be affected by cancer;
- •BMI <25kg/m2;
- •Informed consent to participate in the study
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.
研究组 & 干预措施
Intervention arm (breast cancer)
Experimental
Lipidomic analysis for breast cancer patients
干预措施: Lipidomic analysis for breast cancer patients (Procedure)
Control arm (healthy subject)
Other
Lipidomic analysis for healthy subjects
干预措施: Lipidomic analysis for breast cancer patients (Procedure)
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)
Loading locations...
相似试验
尚未招募
不适用
Clinical, Histological and In-depth Molecular Characterization as Well as Experimental Models of Liver Metastasis From Patients With Breast Cancer in Order to Identify New Potential Treatment Avenues.Liver MetastasesBreast CancerNCT05720676KU Leuven20
已完成
不适用
Proteomic Signature in Breast Cancer: Correlation With Tumor Response to Neo-adjuvant ChemotherapyBreast CancerNCT00911911Centre Oscar Lambret66
招募中
不适用
Transcriptional and Epimetabolic Profile of Breast Carcinoma With Luminal or HER2+ or Locally Advanced Triple-negative Histotype in Patients With/Without Previous Clinical History of Metabolic SyndromeMetabolic SyndromeBreast CancerNCT06261918Fondazione Policlinico Universitario Agostino Gemelli IRCCS120
招募中
不适用
Proteomics and Radiomics Research of Breast Cancer Markers in Tissue, Interstitial Fluid and SerumBreast CancerNCT01042548University of Pittsburgh300
招募中
不适用
Using a Blood Test to Monitor Metastatic Breast Cancer TreatmentMetastatic Breast CancerNCT05804578Dr. Christopher Mueller150