Risk Factors for Benign Breast Disease

Benign Breast Disease Clinical Trial

Official title:

Risk Factors for Benign Breast Disease in Young Adult Women. Case-control Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04127422
• Other study ID #: R.19.08.579
• Status: Recruiting
• Start date: November 28, 2019
• Est. completion date: April 2021

Study information

• Verified date: November 2020
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. Identification of such factors may help preventing and / or treating these conditions.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: April 2021
• Est. primary completion date: February 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Benign Breast Disease
• Breast Diseases

Locations

Country	Name	City	State
Egypt	Mansoura University Cancer center	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Relative risk of benign breast disease associated with hormonal contraception.	for the study and control group, the participant will be asked about current hormonal contraception use.	This outcome will be assessed at baseline (the first hospital visit).
Primary	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.	This outcome will be assessed at baseline (the first hospital visit).
Primary	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).	This outcome will be assessed at baseline (the first hospital visit).
Primary	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).	This outcome will be assessed at baseline (the first hospital visit).
Primary	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).	This outcome will be assessed at baseline (the first hospital visit).