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CompletedNCT03918668MamanutUpdated Jul 20, 2021

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

An observational study in Breast Neoplasm Female, Nutrition Related Cancer and Habits, Diet, sponsored by Instituto de Investigación Hospital Universitario La Paz. Completed at 1 site in Spain. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-20.

Sponsored by Instituto de Investigación Hospital Universitario La Paz · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
66
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.
02

Conditions studied

  • Breast Neoplasm Female
  • Nutrition Related Cancer
  • Habits, Diet
  • Cancer, Breast

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Keywords

  • breast neoplasm
  • cancer
  • risk factor
  • nutrition
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 66 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Instituto de Investigación Hospital Universitario La Paz is the lead sponsor of 100 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Women with a recent diagnosis of breast cancer

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

Exclusion Criteria:

  • Patients with stage IV disease.
  • Associated Eating Disorders.
  • Patients with dementia, mental illness or decreased cognitive function.
  • Pregnant or lactating women.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
66 participants (actual)
Patient registry
No

Interventions

  • BehavioralWomen with recent diagnosis of breast cancer

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

06

What researchers measure

Primary outcomes

  1. Dietary habits of a group of women with pre and post-surgical breast cancer

    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

    Time frame: Six months

07

Study locations

1 site
  • Institute for Health Research IdiPAZ
    Madrid, 28046, Spain
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03918668
Lead sponsor
Instituto de Investigación Hospital Universitario La Paz
Responsible party
Sponsor
First posted
Apr 17, 2019
Start date
Jul 1, 2018
Primary completion
Dec 31, 2018
Completion
Dec 31, 2019
Last update
Jul 20, 2021

Study contacts

Carmen Gómez Candela, Msc
principal investigator · Hospital Universitario La Paz

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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