Risk Factors for Benign Breast Disease

NCT ID: NCT04127422

Last Updated: 2020-11-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-28
• Study Completion Date: 2021-04-30

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.

Conditions

Benign Breast Disease

Keywords

Benign breast disease; Fibrocystic disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

No interventions assigned to this group

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).

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Osama Hussein

Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mansoura University Cancer center

Al Mansurah, , Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

Osama Hussein

Role: primary

Other Identifiers

R.19.08.579

Identifier Type: -

Identifier Source: org_study_id