Prognostic Significance of Bioscore in Nonmetastatic Breast Cancer

NCT ID: NCT03638219

Last Updated: 2021-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

317 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2020-10-16

Brief Summary

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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

Detailed Description

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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 ).

Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Donia Hussein Abd Elhamed

Principle invistigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut University hospital

Asyut, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 25220842 (View on PubMed)

Mohamed RF, Abdelhameed DH, Mohamed MA. Combination of Anatomical and Biological Factors to Predict Disease-Free Survival in Breast Cancer. JCO Glob Oncol. 2023 Mar;9:e2200269. doi: 10.1200/GO.22.00269.

Reference Type DERIVED
PMID: 36888928 (View on PubMed)

Other Identifiers

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Bioscore in breast cancer

Identifier Type: -

Identifier Source: org_study_id

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