Breast CancerBreCaLipNCT06026631
Lipidomic Characterization in Non-metastatic Breast Cancer Women Undergoing Surgery: a Pilot Study.
A study testing Lipidomic analysis for breast cancer patients in people with Breast Cancer and Lipid Cell; Tumor, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Lipid Cell; Tumor, Nutrition Related Cancer
- What is being tested?
- Lipidomic analysis for breast cancer patients
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteItaly
- Study dates
- 30 Sep 2023to 31 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Lipidomic analysis for breast cancer patients
- Medical subject headings
- Breast Neoplasms, Neoplasms, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipidomic analysis for breast cancer patientsProcedure or surgery
Lipidomic analysis for breast cancer patients
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm (breast cancer) | Experimental | Lipidomic analysis for breast cancer patients Receives: Procedure: Lipidomic analysis for breast cancer patients |
| Control arm (healthy subject) | Other | Lipidomic analysis for healthy subjects Receives: Procedure: Lipidomic analysis for breast cancer patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: First day
Secondary outcomes (1)
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.
Measured: First day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start30 Sep 2023
- Primary completion1 Dec 2023
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magno Stefano, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Stefano Magno, MD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06026631
- Sponsor's protocol ID
- FPGemelliIRCCS4663
- Acronym
- BreCaLip
- Status last verified
- Sep 2024
- First submitted
- 10 Aug 2023
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lipidomic Characterization in Non-metastatic Breast Cancer Women Undergoing Surgery: a Pilot Study.
- ClinicalTrials.gov ID
- NCT06026631
- Acronym / sponsor ID
- BreCaLip / FPGemelliIRCCS4663
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 30 Sep 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 7 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm (breast cancer) | Experimental | Procedure: Lipidomic analysis for breast cancer patientsLipidomic analysis for breast cancer patients |
| Control arm (healthy subject) | Other | Procedure: Lipidomic analysis for breast cancer patientsLipidomic analysis for healthy subjects |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lipidomic analysis for breast cancer patientsLipidomic analysis for breast cancer patients | Procedure or surgery | Control arm (healthy subject), Intervention arm (breast cancer) |
Primary outcome
Correlation lipidome and BMI
Time frame: First day
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.
1 secondary outcome
Correlation lipidome and nutrition/anatomical-pathological
Time frame: First day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefano Magno, MD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lipidomic analysis for breast cancer patients in people with Breast Cancer and Lipid Cell; Tumor, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation lipidome and BMI (time frame: First day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024.