Risk Factors for Benign Breast Disease

• Conditions: Benign Breast Disease

• Registration Number: NCT04127422
• Lead Sponsor: Mansoura University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-10-10
• Study First Submitted QC: 2019-10-14
• Study First Posted: 2019-10-15
• Study Start: 2019-11-28
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-18
• Last Update Posted: 2020-11-19
• Primary Completion: 2021-02
• Study Completion: 2021-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

• adult females with current symptoms related to the breast.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relative risk of benign breast disease associated with soda beverage consumption.	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.	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.	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).
Relative risk of benign breast disease associated with obesity.	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.

Trial Locations

Locations (1)

Mansoura University Cancer center; 🇪🇬 Mansoura, Egypt