NCT03638219

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
317

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 20, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2020

Completed
Last Updated

March 18, 2021

Status Verified

March 1, 2021

Enrollment Period

2.7 years

First QC Date

August 16, 2018

Last Update Submit

March 16, 2021

Conditions

Outcome Measures

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)

    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

Interventions

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

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBreast cancer in female patients only.
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • \- 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University hospital

Asyut, Egypt

Location

Related Publications (2)

  • 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.

    PMID: 25220842BACKGROUND
  • 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.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle invistigator

Study Record Dates

First Submitted

August 16, 2018

First Posted

August 20, 2018

Study Start

January 1, 2018

Primary Completion

September 30, 2020

Study Completion

October 16, 2020

Last Updated

March 18, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations