Clinical trial NCT04127422: Risk Factors for Benign Breast Disease
Official title: Risk Factors for Benign Breast Disease in Young Adult Women. Case-control Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Benign Breast Disease
Keywords: Benign breast disease
Fibrocystic disease
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2019-10-15
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult females presenting to the breast outpatient clinic at Mansoura University Oncology Center.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* adult females with current symptoms related to the breast.

Exclusion Criteria:

* Current or past malignancy of the breast.
* Discrete breast mass that necessitate work-up to exclude cancer.
* Current psychiatric morbidity.
* Persons unwilling to participate.

Primary outcomes:
measure: Relative risk of benign breast disease associated with obesity.
timeFrame: This outcome will be assessed at baseline (the first hospital visit).
measure: Relative risk of benign breast disease associated with soda beverage consumption.
timeFrame: This outcome will be assessed at baseline (the first hospital visit).
measure: Relative risk of benign breast disease associated with caffeine beverages consumption.
timeFrame: This outcome will be assessed at baseline (the first hospital visit).
measure: Relative risk of benign breast disease associated with parity.
timeFrame: This outcome will be assessed at baseline (the first hospital visit).
Secondary outcomes:
Other outcomes:
measure: Relative risk of benign breast disease associated with hormonal contraception.
timeFrame: This outcome will be assessed at baseline (the first hospital visit).
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Cancer center
Study officials:
References: