Clinical trial NCT02781116: Risk Assessment Tool in Saudi Arabia
Official title: Risk Assessment Tool for Breast Cancer in Saudi Arabia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Lead sponsor: National Guard Health Affairs
Sponsor class: OTHER_GOV
First posted: 2016-05-24
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All female patients attended the breast cancer screening center

Brief summary: This study will have great impact and influence in the medical setting as the targeted model that will be derived from this study will be the pioneer in our region. This model will be beneficial in identifying risk factors and its association with the Arab women population. Furthermore, it will bring chemotherapy prevention once the risk factors and the model are established. Risk factors maybe different from those identified in western women by Gail and IBIS Models

Detailed description: Breast cancer is the most common cancer worldwide. Incidence and mortality have reached a plateau and appear to be dropping in both United States and parts of Western Europe. This decline has been attributed to several factors such as early detection through the use of screening mammography and appropriate use of systemic adjuvant therapy. Breast cancer is a disease and that is predominantly influenced by risk factors which can be allocated to one of four groups: first, family history / genetic which accounts for 15% of all breast cancer cases. The second group which is the most known risk factor for breast cancer can be linked to hazardous effects of hormonal exposures such as early age at menarche, late age at menopause, small number of children and nulliparity, late age at first birth and little or no breast feeding. Long term use of hormone replacement therapy but apparently not long term use of oral contraceptives is also important. The third group is high mammographic breast density which has been shown to be one of the most significant markers of breast cancer risk and the fourth group is having a history proliferative benign breast disease.

Recently, there is a belief that overall caloric intake and obesity in particular with weight gain are related to increased breast cancer risk with different effects between pre and post menopausal women. Also physical activity appears to be important, above and beyond its effect on weight.

There are scattered studies about breast cancer risk factors in the Arab region. One study was published on March 2002 which investigates risk factors associated with breast cancer in Jordanian women while some studies associate diet with breast cancer. The known / well-established risk factors in the Western countries have not bee systematically validated or proven to play a role in Arab women with breast cancer. Therefore, there is no known risk assessment tool that is applicable to our patient population. No model has not been created yet synthesizing the breast cancer risk factors in Arab women.

Research Impact:

This study will have great impact and influence in the medical setting as the targeted model that will be derived from this study will be the pioneer in our region. This model will be beneficial in identifying risk factors and its association with the Arab women population. Furthermore, it will bring chemotherapy prevention once the risk factors and the model are established. Risk factors maybe different from those identified in western women by Gail and IBIS Models

Eligibility criteria: Inclusion Criteria:

* All female patients attended the breast cancer screening center

Exclusion Criteria:

* Refusal of participation

Primary outcomes:
measure: The number of new breast cancer identified with the new risk assessment model that more applicable for our population
timeFrame: 5 years
Secondary outcomes:
measure: 1. The number of new breast cancer cases using Tyrer Cuzick models that applied in our patients
timeFrame: 5 years
measure: Collect number of IVF and ovarian stimulation in prediction of breast cancer
timeFrame: 5 years
measure: Collect BMI measure in kg/m^2
timeFrame: 5 years
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Abdul Aziz Medical City for National Guard Health Affairs
Study officials:
affiliation: Ministry of National Guard Health Affairs
name: Omalkhair Abulkhair
role: PRINCIPAL_INVESTIGATOR
References: