Lipidomic Characterization in Non-metastatic Breast Cancer Women Undergoing Surgery: a Pilot Study. (NCT06026631) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Lipidomic Characterization in Non-metastatic Breast Cancer Women Undergoing Surgery: a Pilot Study.
Italy65 participantsStarted 2023-09-30
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
* Suffer…