Outcome of Pregnancy and Breast Cancer
Pregnancy
Outcome of Pregnancy Associated Breast Cancer (PABC) in Saudi Arabia ; Prospective Cohort Study.
1 other identifier
observational
20
1 country
1
Brief Summary
Investigators are interested to explore the clinical and pathological characteristics of breast cancer with pregnancy, maternal age at the time of diagnosis of breast cancer during pregnancy, median gestational age at diagnosis, the level of the tumor differentiation patients present with, during pregnancy, and the hormonal-receptor status. Investigators plan to collect prospective quality research databases that could provide further important information concerning this condition and serve in both short- and long-term sequelae in mother and fetus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 31, 2016
CompletedFirst Posted
Study publicly available on registry
May 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2019
CompletedMay 17, 2016
May 1, 2016
5 years
March 31, 2016
May 12, 2016
Conditions
Outcome Measures
Primary Outcomes (5)
To explore the characteristics of pregnancy associated breast cancer (PABC), maternal and fetal outcome of the pregnancy.
5 years
Prevelance and outcome
• To determine the prevalence and incidence of breast cancer in pregnancy
5 years
prevalence and outcome
• To measure the prognostic outcomes of at mother and fetus level in breast cancer with pregnancy
5 years
prevalence and outcome
• To describe the pathological characteristics of breast cancer when it concomitantly present with pregnancy
5 years
prevalence and outcome
• To assess the sensitivity and specification of diagnostic procedure.
5 years
Secondary Outcomes (2)
Long outcome
5 years
Long outcome
5 years
Eligibility Criteria
The study design approach is a cohort study, which planned to recruit all patients attend the breast cancer clinic, interview in details, assessed and followed prospectively for 5 years from the time of diagnoses or till death occurs, whichever occurred first.
You may qualify if:
- All pregnants with breast cancer will be included in this study
You may not qualify if:
- Refusal of pregnant women with 2nd or 3rd trimester to receive chemotherapy, will be excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
King Abdul Aziz Medical City for National Guard Health Affairs
Riyadh, 11426, Saudi Arabia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2016
First Posted
May 17, 2016
Study Start
November 1, 2014
Primary Completion
November 1, 2019
Study Completion
November 1, 2019
Last Updated
May 17, 2016
Record last verified: 2016-05
Data Sharing
- IPD Sharing
- Will not share