Breast CancerNCT06786598
The Effect of Body Mass Index and Total Cholesterol Levels on Histopathological Grading in Breast Cancer Patients
A study testing Cholesterol in people with Breast Cancer, run by Latakia University at 1 site in Syria.
Trial summary
Breast cancer is a widespread cancer that affects high percentiles of women worldwide.The development and aggressiveness of breast cancer cells can be evaluated depending on the histopathological grading which reflects the degree of differentiation. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Cholesterol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteSyria
- Study dates
- 1 Jan 2023to 1 Oct 2023
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- all participants after ensurement that all their clinical and demoghraphical data are completed
Who cannot join
- metabolic syndromes, as well as patients with statin therapy and hormonal replacement treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Breast cancer is a widespread cancer that affects high percentiles of women worldwide.The development and aggressiveness of breast cancer cells can be evaluated depending on the histopathological grading which reflects the degree of differentiation. Several factors related to lifestyle can impact the development of breast cancer. Obesity is an important factor that received the attention in recent years. The using of body mass index(BMI) is still the common method for identifying obesity which is defined when having 30kg/m² or more. Previous epidemiological and clinical studies found that obesity was correlated with advanced breast cancer especially in postmenopausal patients . Also, the changes in cholesterol levels can influence breast cancer risk in the context of obesity. The findings of other studies is still controversial; many studies revealed that elevated total cholesterol levels could increase breast cancer risk while others found to have no effect. Due to the possibility of previous factors' effect on breast cancer progression, we purposed in this study to assess the association of BMI and total cholesterol with histopathological grading according to menopausal status among a group of breast cancer patients in Syria
- Conditions
- Breast Cancer
- Being tested
- Cholesterol
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholesterolDiagnostic test
Qimica/kit
| Study group | Role | What they receive |
|---|---|---|
| cholesterol titration | Experimental | Not described Receives: Diagnostic Test: Cholesterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating The effect of body mass index and total cholesterol levels on histopathological grading in breast cancer patients
Measured: baseline
Assessing the body mass index between patients via dividing weight(in killogram) by height (in meter squared)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start1 Jan 2023
- Primary completion1 Sep 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Latakia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06786598
- Sponsor's protocol ID
- Breast cancer grading
- Other IDs
- Institutional review board
- Status last verified
- Dec 2024
- First submitted
- 12 Jan 2025
- Last updated
- 28 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Llaverias G, Danilo C, Mercier I, Daumer K, Capozza F, Williams TM, Sotgia F, Lisanti MP, Frank PG. Role of cholesterol in the development and progression of breast cancer. Am J Pathol. 2011 Jan;178(1):402-12. doi: 10.1016/j.ajpath.2010.11.005. Epub 2010 Dec 23.
PubMed 21224077
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Body Mass Index and Total Cholesterol Levels on Histopathological Grading in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT06786598
- Acronym / sponsor ID
- Breast cancer grading
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Latakia UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 22 Jan 2025 (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.
Breast cancer is a widespread cancer that affects high percentiles of women worldwide.The development and aggressiveness of breast cancer cells can be evaluated depending on the histopathological grading which reflects the degree of differentiation. Several factors related to lifestyle can impact the development of breast cancer. Obesity is an important factor that received the attention in recent years. The using of body mass index(BMI) is still the common method for identifying obesity which is defined when having 30kg/m² or more. Previous epidemiological and clinical studies found that obesity was correlated with advanced breast cancer especially in postmenopausal patients . Also, the changes in cholesterol levels can influence breast cancer risk in the context of obesity. The findings of other studies is still controversial; many studies revealed that elevated total cholesterol levels could increase breast cancer risk while others found to have no effect. Due to the possibility of previous factors' effect on breast cancer progression, we purposed in this study to assess the association of BMI and total cholesterol with histopathological grading according to menopausal status among a group of breast cancer patients in Syria
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cholesterol titration | Experimental | Diagnostic Test: Cholesterol |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all participants after ensurement that all their clinical and demoghraphical data are completed
Key exclusion criteria (1 listed)
- metabolic syndromes, as well as patients with statin therapy and hormonal replacement treatment.
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 |
|---|---|---|
| CholesterolQimica/kit | Diagnostic test | cholesterol titration |
Primary outcome
Evaluating The effect of body mass index and total cholesterol levels on histopathological grading in breast cancer patients
Time frame: baseline
Assessing the body mass index between patients via dividing weight(in killogram) by height (in meter squared)
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Results publication: PubMed 21224077Llaverias G, Danilo C, Mercier I, Daumer K, Capozza F, Williams TM, Sotgia F, Lisanti MP, Frank PG. Role of cholesterol in the development and progression of breast cancer. Am J Pathol. 2011 Jan;178(1):402-12. doi: 10.1016/j.ajpath.2010.11.005. Epub 2010 Dec 23.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cholesterol in people with Breast Cancer, run by Latakia University at 1 site in Syria.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 28 Jan 2025. 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 Syria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluating The effect of body mass index and total cholesterol levels on histopathological grading in breast cancer patients (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06786598, which also lists 1 linked publication.
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 28 Jan 2025.