NCT03474016

Brief Summary

Breast cancer (BC) is the most common cancer in women worldwide, and is the leading cause of death from cancer among women globally. Mammography is the standard method for early detection of BC in many countries, with over 1.3 million annually new diagnosed cases.In Egypt, breast cancer is the most common cancer in females accounting for 38.8% of all female cancers.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
116

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2018

Status
unknown

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

First Submitted

Initial submission to the registry

March 16, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 22, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

May 21, 2018

Status Verified

May 1, 2018

Enrollment Period

1.5 years

First QC Date

March 16, 2018

Last Update Submit

May 17, 2018

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Diagnostic values of cell free DNA using ALU (Arthrobacter luteus) sequence levels (247 bp (base pair), 115bp) and its integrity in peripheral blood of breast cancer patients as non invasive marker.

    3 days

Study Arms (4)

Patients with early breast cancer(30)

Diagnostic Test: Mammography-Histopathological examination of breast mass specimens- polymerase chain reaction

Patients with advanced breast cancer(30)

Diagnostic Test: Mammography-Histopathological examination of breast mass specimens- polymerase chain reaction

Patients with benign breast diseases(20)

Diagnostic Test: Mammography-Histopathological examination of breast mass specimens- polymerase chain reaction

Apparently healthy females as a control group(36)

Diagnostic Test: Mammography-Histopathological examination of breast mass specimens- polymerase chain reaction

Interventions

Mammography-Histopathological examination of breast mass specimens- polymerase chain reactionDIAGNOSTIC_TEST

Mammography-Histopathological examination of breast mass specimens-Detection of long and short DNA fragments in serum using real-time quantitative polymerase chain reaction

Apparently healthy females as a control group(36)Patients with advanced breast cancer(30)Patients with benign breast diseases(20)Patients with early breast cancer(30)

Eligibility Criteria

Age19 Years - 80 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study will be conducted on one hundred informed and consented female individuals (according to the guidelines of ethical committee of faculty of Medicine, Assuit University and South Egypt Cancer Institute.

You may qualify if:

  • All patients enrolled before initiation of any treatment.

You may not qualify if:

  • Any other malignant or benign tumors.
  • Active inflammatory or autoimmune diseases.
  • Renal or liver diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

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

Study Record Dates

First Submitted

March 16, 2018

First Posted

March 22, 2018

Study Start

July 1, 2018

Primary Completion

January 1, 2020

Study Completion

July 1, 2020

Last Updated

May 21, 2018

Record last verified: 2018-05