Prognostic Significance of Bioscore in Nonmetastatic Breast Cancer (Observational)

March 16, 2021 updated by: Donia Hussein Abd Elhamed, Assiut University

Prognostic Significance of Bioscore in Nonmetastatic Cancer

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 ).

Study Type

Observational

Enrollment (Actual)

317

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Asyut, Egypt
        • Assiut University hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

non metastatic breast cancer patients presenting to our department during period of our study.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: Non metastatic breast cancer patients presented at our department from 2015 to 2018.. Then follow up till 2020
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

September 30, 2020

Study Completion (Actual)

October 16, 2020

Study Registration Dates

First Submitted

August 16, 2018

First Submitted That Met QC Criteria

August 16, 2018

First Posted (Actual)

August 20, 2018

Study Record Updates

Last Update Posted (Actual)

March 18, 2021

Last Update Submitted That Met QC Criteria

March 16, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bioscore in breast cancer

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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