Benign Breast DiseaseNCT04127422
Risk Factors for Benign Breast Disease
An observational study of Benign Breast Disease, run by Mansoura University at 1 site in Egypt.
Trial summary
Benign diseases of the breast are common clinical conditions that affect young women. Complaints related to the breast often cause significant discomfort and mental stress. The following study will try to identify the risk factors that may be associated with symptomatic benign breast diseases. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Benign Breast Disease
- How many people
- 500 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Nov 2019to Apr 2021
- 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 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Adult females presenting to the breast outpatient clinic at Mansoura University Oncology Center.
Who may be able to join
- adult females with current symptoms related to the breast.
Who cannot join
- Current or past malignancy of the breast.
- Discrete breast mass that necessitate work-up to exclude cancer.
- Current psychiatric morbidity.
- Persons unwilling to participate.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura University Cancer center
Al Mansurah, 35516
Osama Hussein, 00201099815110, osama.hussein@mail.mcgill.ca
Saleh Elbalka
About this study
Official title: Risk Factors for Benign Breast Disease in Young Adult Women. Case-control Study
Benign diseases of the breast are common clinical conditions that affect young women. Complaints related to the breast often cause significant discomfort and mental stress. The following study will try to identify the risk factors that may be associated with symptomatic benign breast diseases. Identification of such factors may help preventing and / or treating these conditions.
Read the detailed description
Benign breast disease (BBD) is a common cause of hospital visit. In young adults, benign breast conditions surpass cancer as a cause of symptoms related to the breast. However, breast symptoms may be associated with significant distress and may impose diagnostic difficulties. Moreover, certain pathological entities of benign breast conditions are well known to increase the risk of breast cancer.
Identification of modifiable risk factors associated with symptomatic breast disorders has several potential benefits. Modification of such factors may help decrease patients' distress, hospital visits and indirectly decrease the risk of cancer.
the available data point to the possible association of several environmental factors with symptomatic BBD. Most of the available information points to an association of BBD with anthropometric features, growth pattern, family history of breast conditions and dietary consumption. Substantial evidence are however lacking and further studies are strongly required to better characterize the risk factors of the condition.
In this study, the investigators will systematically collect epidemiological, developmental and clinical data in young patients presenting with breast complaints. The association with disease incidence, pattern and histology will be examined.
- Conditions
- Benign Breast Disease
- Keywords
- Benign breast disease, Fibrocystic disease
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients presenting with current symptoms related to the breast. Adult females aged 18-39 years presenting to the breast outpatient clinic with either mastalgia, nodularity and/or discharge. A questionnaire, physical examination and bilateral breast ultrasonography will be obtained for all patients. A- The questionnaire will contain the following items: 1. symptoms related to the breast. 2. other medical history. 3. menstrual history. 4. obstetric history. 5. rapid screener for beverages and fast food consumption. 6. rapid screener for vegetables and fruit consumption. B- Physical examination will specifically records the following: 1. breast tender point(s). 2. breast nodularity. 3. nipple discharge. 4. weight, height, body mass index (BMI). C- bilateral breast ultrasonography for all patients. D- breast biopsy when clinically indicated as per hospital policy. | |
| Control group | Age-matched healthy volunteers with no current medical conditions. Adult females aged 18-39 years with no current breast problems. These healthy volunteers will be asked to complete the same questionnaire as per the Study group and have anthropometric measure. A- The questionnaire will contain the following items: 1. other medical history. 2. menstrual history. 3. obstetric history. 4. rapid screener for beverages and fast food consumption. 5. rapid screener for vegetables and fruit consumption. B- Physical examination will specifically records the following: 1- weight, height, body mass index (BMI). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative risk of benign breast disease associated with obesity.
For the study and control groups, body mass index will be calculated as the weight (Kg) to square height (m) ratio.
Measured: This outcome will be assessed at baseline (the first hospital visit).
Relative risk of benign breast disease associated with soda beverage consumption.
for the study and control groups, the participant will be asked about soda beverage consumption in the last 30 days. never consumed is scored 0 (lowest score). Three or more times a day is scored 9 (highest score).
Measured: This outcome will be assessed at baseline (the first hospital visit).
Relative risk of benign breast disease associated with caffeine beverages consumption.
for the study and control groups, the participant will be asked about caffeine beverage consumption in the last 30 days. never consumed is scored 0 (lowest score). Three or more times a day is scored 9 (highest score).
Measured: This outcome will be assessed at baseline (the first hospital visit).
Relative risk of benign breast disease associated with parity.
for the study and control groups, the participant will be asked about her parity. response will be either nullipara, primipara, multipara or grand multipara ( 5 or more births).
Measured: This outcome will be assessed at baseline (the first hospital visit).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start28 Nov 2019
- Primary completionFeb 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Breast DiseaseStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Hussein, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04127422
- Sponsor's protocol ID
- R.19.08.579
- Status last verified
- Nov 2020
- First submitted
- 10 Oct 2019
- Last updated
- 19 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Benign Breast Disease in Young Adult Women. Case-control Study
- ClinicalTrials.gov ID
- NCT04127422
- Acronym / sponsor ID
- R.19.08.579
- Conditions
- Benign Breast Disease
- Keywords
- Benign breast disease, Fibrocystic disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 28 Nov 2019 (actual)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 15 Oct 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.
Benign diseases of the breast are common clinical conditions that affect young women. Complaints related to the breast often cause significant discomfort and mental stress. The following study will try to identify the risk factors that may be associated with symptomatic benign breast diseases. Identification of such factors may help preventing and / or treating these conditions.
Detailed description
Benign breast disease (BBD) is a common cause of hospital visit. In young adults, benign breast conditions surpass cancer as a cause of symptoms related to the breast. However, breast symptoms may be associated with significant distress and may impose diagnostic difficulties. Moreover, certain pathological entities of benign breast conditions are well known to increase the risk of breast cancer.
Identification of modifiable risk factors associated with symptomatic breast disorders has several potential benefits. Modification of such factors may help decrease patients' distress, hospital visits and indirectly decrease the risk of cancer.
the available data point to the possible association of several environmental factors with symptomatic BBD. Most of the available information points to an association of BBD with anthropometric features, growth pattern, family history of breast conditions and dietary consumption. Substantial evidence are however lacking and further studies are strongly required to better characterize the risk factors of the condition.
In this study, the investigators will systematically collect epidemiological, developmental and clinical data in young patients presenting with breast complaints. The association with disease incidence, pattern and histology will be examined.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | –Patients presenting with current symptoms related to the breast. Adult females aged 18-39 years presenting to the breast outpatient clinic with either mastalgia, nodularity and/or discharge. A questionnaire, physical examination and bilateral breast ultrasonography will be obtained for all patients. A- The questionnaire will contain the following items: 1. symptoms related to the breast. 2. other medical history. 3. menstrual history. 4. obstetric history. 5. rapid screener for beverages and fast food consumption. 6. rapid screener for vegetables and fruit consumption. B- Physical examination will specifically records the following: 1. breast tender point(s). 2. breast nodularity. 3. nipple discharge. 4. weight, height, body mass index (BMI). C- bilateral breast ultrasonography for all patients. D- breast biopsy when clinically indicated as per hospital policy. |
| Control group | – | –Age-matched healthy volunteers with no current medical conditions. Adult females aged 18-39 years with no current breast problems. These healthy volunteers will be asked to complete the same questionnaire as per the Study group and have anthropometric measure. A- The questionnaire will contain the following items: 1. other medical history. 2. menstrual history. 3. obstetric history. 4. rapid screener for beverages and fast food consumption. 5. rapid screener for vegetables and fruit consumption. B- Physical examination will specifically records the following: 1- weight, height, body mass index (BMI). |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Adult females presenting to the breast outpatient clinic at Mansoura University Oncology Center.
Key inclusion criteria (1 listed)
- adult females with current symptoms related to the breast.
Key exclusion criteria (4 listed)
- Current or past malignancy of the breast.
- Discrete breast mass that necessitate work-up to exclude cancer.
- Current psychiatric morbidity.
- Persons unwilling to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Relative risk of benign breast disease associated with obesity.
Time frame: This outcome will be assessed at baseline (the first hospital visit).
For the study and control groups, body mass index will be calculated as the weight (Kg) to square height (m) ratio.
Relative risk of benign breast disease associated with soda beverage consumption.
Time frame: This outcome will be assessed at baseline (the first hospital visit).
for the study and control groups, the participant will be asked about soda beverage consumption in the last 30 days. never consumed is scored 0 (lowest score). Three or more times a day is scored 9 (highest score).
Relative risk of benign breast disease associated with caffeine beverages consumption.
Time frame: This outcome will be assessed at baseline (the first hospital visit).
for the study and control groups, the participant will be asked about caffeine beverage consumption in the last 30 days. never consumed is scored 0 (lowest score). Three or more times a day is scored 9 (highest score).
Relative risk of benign breast disease associated with parity.
Time frame: This outcome will be assessed at baseline (the first hospital visit).
for the study and control groups, the participant will be asked about her parity. response will be either nullipara, primipara, multipara or grand multipara ( 5 or more births).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2020.
Related trials for Benign Breast Disease
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruiting
Physical Activity, Proliferation and Immune Markers in Benign Breast Tissue
Breast Cancer
Not yet recruiting
Management of Breast Fibroadenoma: Comparing Observation, Microwave Ablation, and Surgical Excision
Fibroadenoma, Breast Fibroadenoma
Enrolling by invitation
Low-field MRI for Breast Cancer Screening
Breast Benign, Malignant Neoplasm of Breast
RecruitingObservational study
ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE) - iSono Health
Breast Cancer, Benign Breast Condition
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.
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 Benign Breast Disease, run by Mansoura University at 1 site in Egypt.
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 1 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: status not confirmed, as of the sponsor's last update on 19 Nov 2020. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative risk of benign breast disease associated with obesity. (time frame: This outcome will be assessed at baseline (the first hospital visit).). The study lists 4 primary outcomes in all. 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 19 Nov 2020.