Breast CancerNCT02282592
Metabolic Syndrome and Female Breast Cancer
An observational study of Breast Cancer, run by Catholic University of Pelotas.
Trial summary
The role among metabolic syndrome and breast cancer risk is not well understood and must be further explored. The objective of this study is to evaluate the association between metabolic syndrome and breast cancer in Southern Brazil. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Observation about the presence of metabolic syndrome
- How many people
- 164 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to Oct 2014
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Between December 2013 and August 2014, newly diagnosed (within 6 months) BC female patients referred to the oncology sector of the Teaching Hospital of the Federal University of Pelotas and to the Radiotherapy and Oncology Center of Santa Casa de Misericordia of Pelotas were invited to the study, before starting any adjuvant or neoadjuvant treatment. Women with a recidivated tumor, HIV infection, renal, heart or liver disease, hypothyroidism or hyperthyroidism, mobility or neurological limitations, chronicle use of corticosteroids, pacemakers or identified with severe edema were excluded. For each cancer case, one female control should be matched for age (± 5 years) and menopausal status (pre and post-menopausal). Apart from being free from all the exclusion criteria used for BC cases, controls should also have no signs of malignant disease. These women were invited to participate in the study while frequenting the Gynecologic Ambulatory of the same institutions, in the same period.
Who may be able to join
- For cases: having newly diagnosed breast cancer without adjuvant or neoadjuvant treatment;
- For controls: having no evidence of cancer; be matched for age and menopausal status with controls
Who cannot join
- Women with a recidivated tumor, HIV infection, renal, heart or liver disease, hypothyroidism or hyperthyroidism, mobility or neurological limitations, chronicle use of corticosteroids, pacemakers or identified with severe edema were excluded.
About this study
Official title: Metabolic Syndrome and Female Breast Cancer: a Case-control Study in Southern Brazil
The role among metabolic syndrome and breast cancer risk is not well understood and must be further explored. The objective of this study is to evaluate the association between metabolic syndrome and breast cancer in Southern Brazil. In this case-control study, breast cancer patients and controls without malignant disease, matched for age (±5 years) and menopausal status, were interviewed and asked to make a glucose, HDL-cholesterol and triglycerides test. Waist circumference and blood pressure were measured using standardized procedures. Metabolic Syndrome was considered by NCEP ATP III (2001) and IDF (2006) definitions. Cases and controls were compared in relation to the presence of diagnosed MetS (yes/no), number of metabolic abnormalities identified (1 to 5) for each definition, and according to each metabolic abnormality cutoff point.
- Conditions
- Breast Cancer
- Being tested
- Observation about the presence of metabolic syndrome
- Keywords
- Metabolic syndrome, case-control study, Breast cancer
- Medical subject headings
- Breast Neoplasms, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation about the presence of metabolic syndromeOther
| Study group | Role | What they receive |
|---|---|---|
| Cases | newly diagnosed (within 6 months) breast cancer patients, before adjuvant or neoadjuvant treatment. Receives: Other: Observation about the presence of metabolic syndrome | |
| Controls | patients without any malignant disease, matched for age an menopausal status with cases. Receives: Other: Observation about the presence of metabolic syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Odds Ratio for Breast Cancer according to the presence of Metabolic Syndrome and its components
Measured: Participants will be evaluated only once before the first appointment with the oncologist (cases with a biopsy) and gynecologist (controls). The blood test results for Metabolic Syndrome parameters were collected in an expected average of 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2014 (estimated)
- Study startNov 2013
- Primary completionAug 2014
- Study completionOct 2014
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.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of Pelotas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafaela Bulow Bergmann, Catholic University of Pelotas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02282592
- Sponsor's protocol ID
- 481.165
- Status last verified
- Oct 2014
- First submitted
- 17 Oct 2014
- Last updated
- 4 Nov 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Syndrome and Female Breast Cancer: a Case-control Study in Southern Brazil
- ClinicalTrials.gov ID
- NCT02282592
- Acronym / sponsor ID
- 481.165
- Conditions
- Breast Cancer
- Keywords
- Metabolic syndrome, case-control study, Breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Catholic University of PelotasUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 4 Nov 2014 (estimated)
- 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 role among metabolic syndrome and breast cancer risk is not well understood and must be further explored. The objective of this study is to evaluate the association between metabolic syndrome and breast cancer in Southern Brazil. In this case-control study, breast cancer patients and controls without malignant disease, matched for age (±5 years) and menopausal status, were interviewed and asked to make a glucose, HDL-cholesterol and triglycerides test. Waist circumference and blood pressure were measured using standardized procedures. Metabolic Syndrome was considered by NCEP ATP III (2001) and IDF (2006) definitions. Cases and controls were compared in relation to the presence of diagnosed MetS (yes/no), number of metabolic abnormalities identified (1 to 5) for each definition, and according to each metabolic abnormality cutoff point.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Other: Observation about the presence of metabolic syndromenewly diagnosed (within 6 months) breast cancer patients, before adjuvant or neoadjuvant treatment. |
| Controls | – | Other: Observation about the presence of metabolic syndromepatients without any malignant disease, matched for age an menopausal status with cases. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Between December 2013 and August 2014, newly diagnosed (within 6 months) BC female patients referred to the oncology sector of the Teaching Hospital of the Federal University of Pelotas and to the Radiotherapy and Oncology Center of Santa Casa de Misericordia of Pelotas were invited to the study, before starting any adjuvant or neoadjuvant treatment. Women with a recidivated tumor, HIV infection, renal, heart or liver disease, hypothyroidism or hyperthyroidism, mobility or neurological limitations, chronicle use of corticosteroids, pacemakers or identified with severe edema were excluded. For each cancer case, one female control should be matched for age (± 5 years) and menopausal status (pre and post-menopausal). Apart from being free from all the exclusion criteria used for BC cases, controls should also have no signs of malignant disease. These women were invited to participate in the study while frequenting the Gynecologic Ambulatory of the same institutions, in the same period.
Key inclusion criteria (2 listed)
- For cases: having newly diagnosed breast cancer without adjuvant or neoadjuvant treatment;
- For controls: having no evidence of cancer; be matched for age and menopausal status with controls
Key exclusion criteria (1 listed)
- Women with a recidivated tumor, HIV infection, renal, heart or liver disease, hypothyroidism or hyperthyroidism, mobility or neurological limitations, chronicle use of corticosteroids, pacemakers or identified with severe edema were excluded.
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 |
|---|---|---|
| Observation about the presence of metabolic syndrome | Other | Cases, Controls |
Primary outcome
Odds Ratio for Breast Cancer according to the presence of Metabolic Syndrome and its components
Time frame: Participants will be evaluated only once before the first appointment with the oncologist (cases with a biopsy) and gynecologist (controls). The blood test results for Metabolic Syndrome parameters were collected in an expected average of 30 days.
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 4 Nov 2014.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Catholic University of Pelotas.
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 2 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 4 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Odds Ratio for Breast Cancer according to the presence of Metabolic Syndrome and its components (time frame: Participants will be evaluated only once before the first appointment with the oncologist (cases with a biopsy) and gynecologist (controls). The blood test results for Metabolic Syndrome parameters were collected in an expected average of 30 days.). 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 4 Nov 2014.