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

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06026631
Collaborator
(none)
65
Enrollment
1
Location
2
Arms
10.3
Anticipated Duration (Months)
6.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Lipidomic analysis for breast cancer patients
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
65 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Lipidomic Characterization in Non-metastatic Breast Cancer Women Undergoing Surgery: a Pilot Study.
Anticipated Study Start Date :
Sep 30, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Aug 10, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fondazione Policlinico Universitario A. Gemelli IRCCS Roma Italy

Sponsors and Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Magno Stefano, Head of UOS Breast Integrative Oncology, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrials.gov Identifier:
NCT06026631
Other Study ID Numbers:
  • FPGemelliIRCCS4663
First Posted:
Sep 7, 2023
Last Update Posted:
Sep 7, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Breast Neoplasms
Body Weight

Study Results

No Results Posted as of Sep 7, 2023