AzTrials
AzTrials

Breast CancerNCT02781116

Risk Assessment Tool in Saudi Arabia

An observational study of Breast Cancer, run by National Guard Health Affairs at 1 site in Saudi Arabia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Breast Cancer
How many people
2,000 participants
Where
1 siteSaudi Arabia
Study dates
Mar 2016to Apr 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: All female patients attended the breast cancer screening center

Who may be able to join

  • All female patients attended the breast cancer screening center

Who cannot join

  • Refusal of participation

Trial locations and contacts

1 site in 1 country.

Omalkhair Abulkhair contact

AbulkhairO@NGHA.MED.SA

Nagham Sheblaq contact

oncologyresearch@ngha.med.sa

Saudi Arabia1 site, 1 recruiting
  • King Abdul Aziz Medical City for National Guard Health Affairs

    Riyadh, 11426

    Omalkhair Abulkhair, MD, 0096612520088 ext. 141077, abulkhairo@ngha.med.sa

    Oncology Research, 0096612520088 ext. 14601, oncologyresearch@ngha.med.sa

    Recruiting

Other trials in Saudi Arabia

About this study

Official title: Risk Assessment Tool for Breast Cancer in Saudi Arabia

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

Read the 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

Conditions
Breast Cancer
Medical subject headings
Breast Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The number of new breast cancer identified with the new risk assessment model that more applicable for our population

    Measured: 5 years

Secondary outcomes (3)
  1. 1. The number of new breast cancer cases using Tyrer Cuzick models that applied in our patients

    Measured: 5 years

  2. Collect number of IVF and ovarian stimulation in prediction of breast cancer

    Measured: 5 years

  3. Collect BMI measure in kg/m^2

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2016 (estimated)
  2. Study startMar 2016
  3. Primary completionApr 2019 (estimated)
  4. Study completionApr 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02781116
Sponsor's protocol ID
Risk Assessment
Status last verified
May 2016
First submitted
31 Mar 2016
Last updated
24 May 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer, run by National Guard Health Affairs at 1 site in Saudi Arabia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Omalkhair Abulkhair (AbulkhairO@NGHA.MED.SA), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number of new breast cancer identified with the new risk assessment model that more applicable for our population (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2016.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in