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

Not Applicable

Active, not recruiting

• Conditions: Body Weight; Nutrition Related Cancer; Breast Cancer; Lipid Cell; Tumor
• Interventions: Procedure: Lipidomic analysis for breast cancer patients

• Registration Number: NCT06026631
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-10
• Study First Submitted QC: 2023-09-04
• Study First Posted: 2023-09-07
• Study Start: 2023-09-30
• Primary Completion: 2023-12-01
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-25
• Last Update Posted: 2024-09-27
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 65

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention arm (breast cancer)	Lipidomic analysis for breast cancer patients	Lipidomic analysis for breast cancer patients
Control arm (healthy subject)	Lipidomic analysis for breast cancer patients	Lipidomic analysis for healthy subjects

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS; 🇮🇹 Roma, Italy