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出境医 / 临床实验 / Study for the Knowledge of Risk Factors Associated With Breast Cancer in Women (Mamanut)

Study for the Knowledge of Risk Factors Associated With Breast Cancer in Women (Mamanut)

Study Description
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.


Condition or disease Intervention/treatment
Breast Neoplasm Female Nutrition Related Cancer Habits, Diet Cancer, Breast Behavioral: Women with recent diagnosis of breast cancer

Detailed Description:
  1. Storage of biological sample at the Hospital.
  2. Patient's breast pathology characteristics.
  3. Study of concomitant pathologies.
  4. Dietary study: "Frequency of Food Consumption" questionnaire referring to the last year eating habits before having been breast cancer diagnosed.
  5. Physical activity study in the year prior to the diagnosis of breast cancer.
  6. Anthropometric study: weight, size, waist circumference and body composition (% Fat mass,% Lean mass,% Body water).
  7. Study of other risk factors of breast cancer: age, family history, reproductive history, medications consumed...
  8. Biochemical study: biochemical variables of the last blood analysis performed on the volunteer in the hospital center.
  9. Saliva collection to proceed with the genetic analysis.
  10. Collection of stool sample to carry out the microbiota study.
Study Design
Layout table for study information
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
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. 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



Eligibility Criteria
Contacts and Locations
Tracking Information
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
 (submitted: June 26, 2019)
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
Original Primary Outcome Measures
 (submitted: April 16, 2019)
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
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.

Detailed Description
  1. Storage of biological sample at the Hospital.
  2. Patient's breast pathology characteristics.
  3. Study of concomitant pathologies.
  4. Dietary study: "Frequency of Food Consumption" questionnaire referring to the last year eating habits before having been breast cancer diagnosed.
  5. Physical activity study in the year prior to the diagnosis of breast cancer.
  6. Anthropometric study: weight, size, waist circumference and body composition (% Fat mass,% Lean mass,% Body water).
  7. Study of other risk factors of breast cancer: age, family history, reproductive history, medications consumed...
  8. Biochemical study: biochemical variables of the last blood analysis performed on the volunteer in the hospital center.
  9. Saliva collection to proceed with the genetic analysis.
  10. Collection of stool sample to carry out the microbiota study.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Women with a recent diagnosis of breast cancer
Condition
  • Breast Neoplasm Female
  • Nutrition Related Cancer
  • Habits, Diet
  • Cancer, Breast
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
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.
 
Recruitment Information
Recruitment Status Unknown status
Actual Enrollment
 (submitted: April 16, 2019)
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:

  • Older women than 18 years old
  • Newly diagnosed patients with a breast tumor (Phase I, II or III). Being in one of the following cases:

    1. Patient who has not yet received any treatment and the committee has decided that as a first treatment will receive chemo or radiotherapy.
    2. Patient who has just undergone surgery and is waiting to start adjuvant treatment with chemo or radiotherapy.
  • Sign the informed consent.

Exclusion Criteria:

  • Patients with stage IV disease.
  • Associated Eating Disorders.
  • Patients with dementia, mental illness or decreased cognitive function.
  • Pregnant or lactating women.
Sex/Gender
Sexes Eligible for Study: Female
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Instituto de Investigación Hospital Universitario La Paz
Study Sponsor Instituto de Investigación Hospital Universitario La Paz
Collaborators Not Provided
Investigators
Principal Investigator: Carmen Gómez Candela, Msc Hospital Universitario La Paz
PRS Account Instituto de Investigación Hospital Universitario La Paz
Verification Date February 2019

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