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

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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Key information

Conditions

Breast Neoplasm Female Behavior Behavior, Animal Breast Diseases Breast Neoplasms Cancer, Breast Feeding Behavior Habits, Diet Neoplasms Neoplasms by Site Nutrition Related Cancer Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Institute for Health Research IdiPAZ

Madrid, 28046, Spain

About this study

Storage of biological sample at the Hospital.
Patient's breast pathology characteristics.
Study of concomitant pathologies.
Dietary study: "Frequency of Food Consumption" questionnaire referring to the last year eating habits before having been breast cancer diagnosed.
Physical activity study in the year prior to the diagnosis of breast cancer.
Anthropometric study: weight, size, waist circumference and body composition (% Fat mass,% Lean mass,% Body water).
Study of other risk factors of breast cancer: age, family history, reproductive history, medications consumed...
Biochemical study: biochemical variables of the last blood analysis performed on the volunteer in the hospital center.
Saliva collection to proceed with the genetic analysis.
Collection of stool sample to carry out the microbiota study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

Patient who has not yet received any treatment and the committee has decided that as a first treatment will receive chemo or radiotherapy.
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.

Treatment and study plan

Women with recent diagnosis of breast cancer

Behavioral

To evaluate dietary habits of a group of women with pre and post-surgical breast cancer

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Hospital Universitario La Paz

Other

Registry information

Official study title

Observational Study to Understand the Risk Factors Associated With Breast Cancer in Women With a Recent Diagnosis at the Community of Madrid

Acronym: Mamanut

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2019
First posted: Apr 17, 2019
Registry last updated: Jul 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed