Clinical trial NCT06026631: Lipidomic Characterization in Non-metastatic Breast Cancer Women Undergoing Surgery: a Pilot Study.
Official title: Lipidomic Characterization in Non-metastatic Breast Cancer Women Undergoing Surgery: a Pilot Study.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Lipid Cell; Tumor
Nutrition Related Cancer
Body Weight
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-09-07
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Correlation lipidome and BMI
timeFrame: First day
Secondary outcomes:
measure: Correlation lipidome and nutrition/anatomical-pathological
timeFrame: First day
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Stefano Magno, MD
role: PRINCIPAL_INVESTIGATOR
References: