Breast Neoplasm FemaleMamanutNCT03918668
Study for the Knowledge of Risk Factors Associated With Breast Cancer in Women
An observational study of Breast Neoplasm Female and Nutrition Related Cancer, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasm Female, Nutrition Related Cancer, Habits, Diet
- What is being tested?
- Women with recent diagnosis of breast cancer
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 66 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2018to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with a recent diagnosis of breast cancer
Who may be able to join
- 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.
Who cannot join
- Patients with stage IV disease.
- Associated Eating Disorders.
- Patients with dementia, mental illness or decreased cognitive function.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study to Understand the Risk Factors Associated With Breast Cancer in Women With a Recent Diagnosis at the Community of Madrid
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
- 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.
- Being tested
- Women with recent diagnosis of breast cancer
- Keywords
- breast neoplasm, cancer, risk factor, nutrition
- Medical subject headings
- Feeding Behavior, Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Women with recent diagnosis of breast cancerBehavioural
To evaluate dietary habits of a group of women with pre and post-surgical breast cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start1 Jul 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Neoplasm FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carmen Gómez Candela, Msc, Principal investigator, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03918668
- Sponsor's protocol ID
- PI-2842
- Acronym
- Mamanut
- Status last verified
- Feb 2019
- First submitted
- 28 Feb 2019
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Understand the Risk Factors Associated With Breast Cancer in Women With a Recent Diagnosis at the Community of Madrid
- ClinicalTrials.gov ID
- NCT03918668
- Acronym / sponsor ID
- Mamanut / PI-2842
- Keywords
- breast neoplasm, cancer, risk factor, nutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 17 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with a recent diagnosis of breast cancer
Key inclusion criteria (5 listed)
- 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:
- Sign the informed consent.
Key exclusion criteria (4 listed)
- Patients with stage IV disease.
- Associated Eating Disorders.
- Patients with dementia, mental illness or decreased cognitive function.
- Pregnant or lactating women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Women with recent diagnosis of breast cancerTo evaluate dietary habits of a group of women with pre and post-surgical breast cancer | Behavioural | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmen Gómez Candela, Msc principal investigator
Hospital Universitario La Paz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasm Female and Nutrition Related Cancer, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dietary habits of a group of women with pre and post-surgical breast cancer (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2021.