Ignite Creation Date:
2024-05-06 @ 1:02 PM
Last Modification Date:
2024-10-26 @ 1:08 PM
Study NCT ID:
NCT03918668
Status:
COMPLETED
Last Update Posted:
2021-07-20
First Post:
2019-02-28
Brief Title:
Study for the Knowledge of Risk Factors Associated With Breast Cancer in Women
Sponsor:
Instituto de Investigación Hospital Universitario La Paz
Organization:
Instituto de Investigación Hospital Universitario La Paz
Study Overview
Official Title:
Observational Study to Understand the Risk Factors Associated With Breast Cancer in Women With a Recent Diagnosis at the Community of Madrid
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Mamanut
Brief Summary:
Breast cancer is the most frequent tumor in Western women In Spain about 26000 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 arent 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
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 arent 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 Patients 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
2 Patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None