1. SYNOPSIS OF THE PROTOCOL
Title: Pregnancy Associated Breast Cancer (PABC); Prospective Data Registry in Saudi Arabia
Sponsor: Oncology Department, King Abdulaziz Medical City, Riyadh

2. Indication:
The study design approach is a disease registry which planned to recruit all patients attend the breast cancer clinic, interviewed in details, assessed and followed prospectively for 5 years from the time of diagnosis or till death occurs, whichever occurred first..

3. Objectives:
Primary
To determine the prevalence and incidence of breast cancer in pregnancy
To describe prognostic outcomes of at mother and fetus level in breast cancer with pregnancy
To describe the pathological characteristics of breast cancer when it concomitantly present with pregnancy
To assess the sensitivity and specification of diagnostic procedure.
Secondary
To know the outcome of newborn after 1st and 5th year.
To know the outcome of breast cancer after 5 years from diagnosis

4. Trial Design:
The study design approach is a disease registry which planned to recruit all patients attend the breast cancer clinic, interviewed in details, assessed and followed prospectively for 5 years from the time of diagnosis or till death occurs, whichever occurred first.

5. Number of Patients:
Convenient sample will be applied (availability sample) to recruit all pregnant with breast cancer seen in the adult oncology clinic

6. All pregnant with breast cancer will be included in this study
Selection criteria:
All pregnant with breast cancer will be included in this study

7. Study duration
The study will be conducted at National Guard Hospital, Oncology Department or participating sites.

8. Procedures (summary):
This is a prospective data registry where paper CRF will be attached with this proposal and electronic CRF will be available on Intranet/Oncology website.
In the study we will prospectively assess; screening, diagnosis, treatment options, and prognosis of breast cancer associated with pregnancy, aiming to collect full history of (personal, family, environmental, and genetics) and to give optimal treatment to the mother to maximize the chances of survival, whilst minimizing the risks of harm to the fetus. Patients will be followed prospectively for a period of 5 years or until patient's death whichever occurs first.
Data will be collected via a case report form at each patient’s visit from patient medical records; tissue and blood sample will be collected and stored. Samples for DNA or tissue for bio banking will be obtained.
Due to the nature of the study being descriptive, and observation only so convenient sample and sampling techniques will be applied recruiting every patient attend the clinic and consented, there is also no pre-formatted hypothesis. Interim analysis every 6 months will be conducted and both descriptive and analytic statistics will be reported

9. Contact details: SPONSOR
Name: Oncology Department, King Abdulaziz Medical City, Riyadh
Address: P.O. Box Riyadh 11426, K.S.A
Tel: (966) Ext