Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06026631

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lipidomic analysis for breast cancer patients

Procedure

Lipidomic analysis for breast cancer patients

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Acronym: BreCaLip

Important dates

Study start
2023
Primary completion
2023
Study completion
2025
First posted
Sep 7, 2023
Registry last updated
Sep 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.