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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-30

Study Completion Date

2025-08-31

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.

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Detailed Description

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Conditions

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Breast Cancer Lipid Cell; Tumor Nutrition Related Cancer Body Weight

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Intervention arm (breast cancer)

Lipidomic analysis for breast cancer patients

Group Type EXPERIMENTAL

Lipidomic analysis for breast cancer patients

Intervention Type PROCEDURE

Lipidomic analysis for breast cancer patients

Control arm (healthy subject)

Lipidomic analysis for healthy subjects

Group Type OTHER

Lipidomic analysis for breast cancer patients

Intervention Type PROCEDURE

Lipidomic analysis for breast cancer patients

Interventions

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Lipidomic analysis for breast cancer patients

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes