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

NCT06026631 | Active Not Recruiting DMC

• 1 other identifier: FPGemelliIRCCS4663
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Correlation lipidome and nutrition/anatomical-pathological

  First day

Study Arms (2)

Intervention arm (breast cancer)

EXPERIMENTAL

Lipidomic analysis for breast cancer patients

Procedure: Lipidomic analysis for breast cancer patients

Control arm (healthy subject)

OTHER

Lipidomic analysis for healthy subjects

Procedure: Lipidomic analysis for breast cancer patients

Interventions

Lipidomic analysis for breast cancer patients PROCEDURE

Lipidomic analysis for breast cancer patients

Control arm (healthy subject); Intervention arm (breast cancer)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms; Body Weight

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stefano Magno, MD

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of UOS Breast Integrative Oncology

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: September 7, 2023
• Study Start: September 30, 2023
• Primary Completion: December 1, 2023
• Study Completion: August 31, 2025
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)