Body Weight, Breast Cancer, Lipid Cell; Tumor, Nutrition Related Cancer
Conditions
Brief summary
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.
Interventions
PROCEDURELipidomic analysis for breast cancer patients
Lipidomic analysis for breast cancer patients
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation lipidome and BMI | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation lipidome and nutrition/anatomical-pathological | First day | 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. |
Countries
Italy
Outcome results
None listed