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

September 25, 2024 updated by: Magno Stefano, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy
        • Fondazione Policlinico Universitario A. Gemelli IRCCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention arm (breast cancer)
Lipidomic analysis for breast cancer patients
Procedure: Lipidomic analysis for breast cancer patients
Lipidomic analysis for breast cancer patients
Other: Control arm (healthy subject)
Lipidomic analysis for healthy subjects
Procedure: Lipidomic analysis for breast cancer patients
Lipidomic analysis for breast cancer patients

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation lipidome and nutrition/anatomical-pathological
Time Frame: 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.
First day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Stefano Magno, MD, Fondazione Policlinico Universitario A. gemelli, IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2023

Primary Completion (Actual)

December 1, 2023

Study Completion (Estimated)

August 31, 2025

Study Registration Dates

First Submitted

August 10, 2023

First Submitted That Met QC Criteria

September 4, 2023

First Posted (Actual)

September 7, 2023

Study Record Updates

Last Update Posted (Actual)

September 27, 2024

Last Update Submitted That Met QC Criteria

September 25, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FPGemelliIRCCS4663

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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