SYNOPSIS OF THE PROTOCOL
Title: Pregnancy Associated Breast Cancer (PABC); Prospective Data
Registry in Saudi Arabia
Sponsor: Oncology Department, King Abdulaziz Medical City,
Riyadh
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..
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
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.
Number of Patients:
Convenient sample will be applied (availability sample) to recruit all
pregnant with breast cancer seen in the adult oncology clinic
Selection criteria:
All pregnant with breast cancer will be included in this study
Study duration
The study will be conducted at National Guard Hospital, Oncology
Department or participating sites.
Procedures (summary):
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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
Contact details:
SPONSOR
Name: Oncology Department, King Abdulaziz Medical City, Riyadh
Address: P.O. Box 22490 Riyadh 11426, K.S.A
Tel: (966)-1-2520088 Ext. 12856
Email: OncologyResearch@ngha.med.sa