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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Active, not recruiting

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

Treatments: Procedure: Lipidomic analysis for breast cancer patients

Study type: Interventional

Funder types: Other

Identifiers

NCT06026631

FPGemelliIRCCS4663

Details and patient eligibility

About

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.

Enrollment: 65 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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65 participants in 2 patient groups

Intervention arm (breast cancer)

Experimental group

Description:

Lipidomic analysis for breast cancer patients

Treatment:

Procedure: Lipidomic analysis for breast cancer patients

Control arm (healthy subject)

Other group

Description:

Lipidomic analysis for healthy subjects

Treatment:

Procedure: Lipidomic analysis for breast cancer patients