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

Breast Cancer Clinical Trial

— BreCaLip  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06026631
• Other study ID #: FPGemelliIRCCS4663
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 30, 2023
• Est. completion date: August 10, 2024

Study information

• Verified date: September 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Stefano Magno, MD
• Phone: +39 06 3015 7077
• Email: stefano.magno[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 65
• Est. completion date: August 10, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Breast Cancer
• Breast Neoplasms
• Nutrition Related Cancer

Intervention

Procedure:
• Lipidomic analysis for breast cancer patients
Lipidomic analysis for breast cancer patients

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario A. Gemelli IRCCS	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation lipidome and BMI	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	Correlation lipidome and nutrition/anatomical-pathological	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