Lipidomic Characterization in Non-metastatic Breast Cancer Women Undergoing Surgery: a Pilot Study.

Study Overview
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Brief Summary
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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.

Official Title
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Lipidomic Characterization in Non-metastatic Breast Cancer Women Undergoing Surgery: a Pilot Study.

Conditions
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Breast Cancer, Lipid Cell; Tumor, Nutrition Related Cancer, Body Weight

Intervention / Treatment
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* Procedure: Lipidomic analysis for breast cancer patients


Participation Criteria
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Eligibility Criteria
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Patients 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. controls Age <65 years; Not be affected by cancer; BMI <25kg/m2; Informed consent to participate in the study Exclusion Criteria: patients 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. controls Age ≥65 years; Suffering from tumor pathology; BMI ≥25kg/m2; Refusal to sign informed consent to participate in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm (breast cancer)<br>Lipidomic analysis for breast cancer patients | Procedure: Lipidomic analysis for breast cancer patients<br>* Lipidomic analysis for breast cancer patients<br>|
| Other: Control arm (healthy subject)<br>Lipidomic analysis for healthy subjects | Procedure: Lipidomic analysis for breast cancer patients<br>* Lipidomic analysis for breast cancer patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation lipidome and BMI | 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. | First day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation lipidome and nutrition/anatomical-pathological | Evaluate the correlation of molecular data with biochemical, nutritional and anatomical-pathological data of the patients and of the tumor (NLR -neutrophil-to-lymphocyte ratio), glycemia, cholesterol, blood pressure, triglycerides; TILs (percentage of lymphocytic infiltrate) and Ki67 (proliferation factor) on the surgical sample; W/H ratio, % FAT, % LEAN, phase angle at bioimpedance analysis in the study sample. | First day |