Breast cancer is the most frequent tumor in Western women. In Spain about 26,000 new breast cancers are diagnosed each year. This type of tumor is increasing worldwide with an increase in aggressive neoplasms in young women. There are some risk factors responsible for this global increase: lifestyle, diet and body weight especially in postmenopausal women.
Some cell mutations, especially in the BRCA1, BRCA2 and p53 genes, are associated with a very high risk of this type of cancer. Some authors have calculated the contribution of various modifiable risk factors to the global burden of breast cancer, and they concluded that 21% of all breast cancer deaths are attributable to alcohol consumption, overweight and obesity, and lack of physical activity. Nowadays, there aren't specific studies in the Community of Madrid designed to know the risk factors related to breast cancer.
For this reason, it is proposed to carry out an observational study that collects detailed information about dietary habits, genetic factors and life quality of a group of women with recent diagnosis in pre or post-surgical phase.
Condition or disease | Intervention/treatment |
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Breast Neoplasm Female Nutrition Related Cancer Habits, Diet Cancer, Breast | Behavioral: Women with recent diagnosis of breast cancer |
Study Type : | Observational |
Actual Enrollment : | 66 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Observational Study to Understand the Risk Factors Associated With Breast Cancer in Women With a Recent Diagnosis at the Community of Madrid |
Actual Study Start Date : | July 1, 2018 |
Actual Primary Completion Date : | December 31, 2018 |
Estimated Study Completion Date : | December 31, 2019 |
Frequency of Consumption of food questionnaire referring. The frequency varies between one time per day and one time per month for every type of food during the last 6 months.
to the last year of the volunteer's eating habits before being breast cancer diagnosed
Tracking Information | |||||
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First Submitted Date | February 28, 2019 | ||||
First Posted Date | April 17, 2019 | ||||
Last Update Posted Date | January 13, 2020 | ||||
Actual Study Start Date | July 1, 2018 | ||||
Actual Primary Completion Date | December 31, 2018 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
Dietary habits of a group of women with pre and post-surgical breast cancer [ Time Frame: Six months ] Frequency of Consumption of food questionnaire referring. The frequency varies between one time per day and one time per month for every type of food during the last 6 months.
to the last year of the volunteer's eating habits before being breast cancer diagnosed
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Original Primary Outcome Measures |
Dietary habits of a group of women with pre and post-surgical breast cancer [ Time Frame: Six months ] Frequency of Consumption of food questionnaire referring to the last year of the volunteer's eating habits before being breast cancer diagnosed
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Change History | |||||
Current Secondary Outcome Measures | Not Provided | ||||
Original Secondary Outcome Measures | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Study for the Knowledge of Risk Factors Associated With Breast Cancer in Women | ||||
Official Title | Observational Study to Understand the Risk Factors Associated With Breast Cancer in Women With a Recent Diagnosis at the Community of Madrid | ||||
Brief Summary |
Breast cancer is the most frequent tumor in Western women. In Spain about 26,000 new breast cancers are diagnosed each year. This type of tumor is increasing worldwide with an increase in aggressive neoplasms in young women. There are some risk factors responsible for this global increase: lifestyle, diet and body weight especially in postmenopausal women. Some cell mutations, especially in the BRCA1, BRCA2 and p53 genes, are associated with a very high risk of this type of cancer. Some authors have calculated the contribution of various modifiable risk factors to the global burden of breast cancer, and they concluded that 21% of all breast cancer deaths are attributable to alcohol consumption, overweight and obesity, and lack of physical activity. Nowadays, there aren't specific studies in the Community of Madrid designed to know the risk factors related to breast cancer. For this reason, it is proposed to carry out an observational study that collects detailed information about dietary habits, genetic factors and life quality of a group of women with recent diagnosis in pre or post-surgical phase. |
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Detailed Description |
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Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Probability Sample | ||||
Study Population | Women with a recent diagnosis of breast cancer | ||||
Condition |
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Intervention | Behavioral: Women with recent diagnosis of breast cancer
To evaluate dietary habits of a group of women with pre and post-surgical breast cancer
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Study Groups/Cohorts | Not Provided | ||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Unknown status | ||||
Actual Enrollment |
66 | ||||
Original Actual Enrollment | Same as current | ||||
Estimated Study Completion Date | December 31, 2019 | ||||
Actual Primary Completion Date | December 31, 2018 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | Spain | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03918668 | ||||
Other Study ID Numbers | PI-2842 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Instituto de Investigación Hospital Universitario La Paz | ||||
Study Sponsor | Instituto de Investigación Hospital Universitario La Paz | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | Instituto de Investigación Hospital Universitario La Paz | ||||
Verification Date | February 2019 |