Risk Factors for Benign Breast Disease

NCT04127422 | Unknown

• 1 other identifier: R.19.08.579
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Breast Disease

Keywords

Benign breast disease; Fibrocystic disease

Outcome Measures

Primary Outcomes (4)

• 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).

• 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).

• 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).

• 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).

Other Outcomes (1)

• Relative risk of benign breast disease associated with hormonal contraception.

  This outcome will be assessed at baseline (the first hospital visit).

Study Arms (2)

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).

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adult females presenting to the breast outpatient clinic at Mansoura University Oncology Center.

You may qualify if:

• adult females with current symptoms related to the breast.

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University Cancer center

Al Mansurah, 35516, Egypt

RECRUITING

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: October 15, 2019
• Study Start: November 28, 2019
• Primary Completion: February 1, 2021
• Study Completion: April 1, 2021
• Last Updated: November 19, 2020

Record last verified: 2020-11

Locations

EG (1)