Prognostic Significance of Bioscore in Nonmetastatic Breast Cancer

Breast Cancer Clinical Trial

— Observational  

Official title:

Prognostic Significance of Bioscore in Nonmetastatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03638219
• Other study ID #: Bioscore in breast cancer
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: October 16, 2020

Study information

• Verified date: March 2021
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

assess the validity of applying the bioscore system to predict the disease-free survival (The percentage of people in a study or treatment group who have not experienced disease relapse in a defined period of time.) in breast cancer patients presenting to our

Description:

Retrospective cohort analysis of breast cancer patient's records for patients treated with surgery as an initial intervention at our department from 2015 to 2018 will be identified. Multivariate analyses of factors, including pathological stage (PS), T stage (T), nodal stage (N), grade (G), estrogen receptor (ER) status (E) and human epidermal growth factor receptor (HER2) status will be recorded to identify associations with disease-free survival DFS. A score of 0-4 will be assigned for each factor by considering the hazard ratio magnitude.

Analysis of the correlation between pathological stage, T stage (T), nodal stage (N), grade (G), estrogen receptor (ER) status (E) and human epidermal growth factor receptor (HER2) status combined score and the disease free survival (DFS ).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 317
• Est. completion date: October 16, 2020
• Est. primary completion date: September 30, 2020
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Female patients Newly diagnosed breast cancer patients presented to clinical oncology department, Assiut University in the period between (2015_2018).

Histologically confirmed invasive breast carcinoma (IBC) Age: =18 and older Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. Complete medical records and follow up

Exclusion Criteria:

• Male patients No definitive surgery Incomplete medical records or follow-up status Unavailability of hormonal receptor status Carcinoma in situ or other rare tumors of the breast as phylloides tumors, pregnancy and lactation

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Data collection about eligible patients presented to our department from 2015 to 2018. Then follow up till 2020.
Data collection, follow up and bioscore calculation at the end of study

Locations

Country	Name	City	State
Egypt	Assiut University hospital	Asyut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the correlation between pathological stage, T stage (T), nodal stage (N), grade (G), estrogen receptor (ER) status (E) and human epidermal growth factor receptor (HER2) status combined score and the disease specific survival (DSS)	Disease free survial:The percentage of people in a study or treatment group who have not experienced disease relapse in a defined period of time. The time period usually begins after surgerical treatment and ends at the end of study period 2020	Non metastatic breast cancer patients presented at our department from 2015 to 2018.. Then follow up till 2020