Status:
ACTIVE_NOT_RECRUITING
Lipidomic Characterization in Non-metastatic Breast Cancer Women Undergoing Surgery: a Pilot Study.
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Breast Cancer
Lipid Cell; Tumor
Eligibility:
FEMALE
18-65 years
Phase:
NA
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 highl...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2025
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT06026631
Start Date
September 30 2023
End Date
August 31 2025
Last Update
September 27 2024
Active Locations (1)
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1
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, Italy