Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Risk Factors for Benign Breast Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04127422
Recruitment Status : Recruiting
First Posted : October 15, 2019
Last Update Posted : January 3, 2020
Sponsor:
Information provided by (Responsible Party):
Osama Hussein, 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.

Condition or disease
Benign Breast Disease

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Risk Factors for Benign Breast Disease in Young Adult Women. Case-control Study
Actual Study Start Date : November 28, 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Diseases

Group/Cohort
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).




Primary Outcome Measures :
  1. Relative risk of benign breast disease associated with obesity. [ Time Frame: 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.

  2. Relative risk of benign breast disease associated with soda beverage consumption. [ Time Frame: 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).

  3. Relative risk of benign breast disease associated with caffeine beverages consumption. [ Time Frame: 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).

  4. Relative risk of benign breast disease associated with parity. [ Time Frame: 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).


Other Outcome Measures:
  1. Relative risk of benign breast disease associated with hormonal contraception. [ Time Frame: This outcome will be assessed at baseline (the first hospital visit). ]
    for the study and control group, the participant will be asked about current hormonal contraception use.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adult females presenting to the breast outpatient clinic at Mansoura University Oncology Center.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04127422


Locations
Layout table for location information
Egypt
Mansoura University Cancer center Recruiting
Mansoura, Egypt, 35516
Contact: Osama Hussein    00201099815110    osama.hussein@mail.mcgill.ca   
Sub-Investigator: Saleh Elbalka         
Sub-Investigator: Ahmed Shoman         
Sponsors and Collaborators
Mansoura University

Layout table for additonal information
Responsible Party: Osama Hussein, Professor of Surgery, Mansoura University
ClinicalTrials.gov Identifier: NCT04127422    
Other Study ID Numbers: R.19.08.579
First Posted: October 15, 2019    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: January 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Osama Hussein, Mansoura University:
Benign breast disease
Fibrocystic disease
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Diseases
Fibrocystic Breast Disease
Skin Diseases