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OpenTrials
Completed

NCT Number: NCT03638219

Prognostic Significance of Bioscore in Nonmetastatic Breast 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

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Assiut University hospital

Asyut, Egypt

About this study

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 ).

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data collection about eligible patients presented to our department from 2015 to 2018. Then follow up till 2020.

Other

Data collection, follow up and bioscore calculation at the end of study

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Prognostic Significance of Bioscore in Nonmetastatic Cancer

Acronym: Observational

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 20, 2018
Registry last updated
Mar 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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