NCT04778202

Brief Summary

The aim of this study is to evaluate the role of miRNA 125a -5p and miRNA143-3p as a non invasive biomarker in diagnosis of breast cancer and the relationship between MiRNA expression and histopathological features as tumor stage ,grade ,molecular subtypes. Also trying to correlate the results with MRI radiological findings which may help in better selection of treatment protocols.

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2022

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

February 25, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 2, 2021

Completed
12 months until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

March 8, 2021

Status Verified

March 1, 2021

Enrollment Period

1 year

First QC Date

February 25, 2021

Last Update Submit

March 4, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • assessment of the value of MiRNA in diagnosis and prognosis of breast cancer patients

    To evaluate diagnostic and prognostic role of MiRNA 125a-5p and 143-3p as a non invasive biomarker in breast cancer

    18-24 month

  • correlat MiRNA expression with MRI findings for better selection of treatment plan and out come

    Also trying to correlate the results with MRI radiological findings which may help in better selection of treatment protocols.

    18-24 months

Study Arms (2)

first group (control group)

25 normal health control women apparently healthy. blood samples will be obtained after getting informed consent

Diagnostic Test: blood sample collection

Second group (breast cancer patient group)

25 female patients referred to radiology departement at South Egypt Cancer Institute or Assiut University Hospital diagnosed as breast cancer patients as evidenced by clinical examination , mammography and histopathology

Diagnostic Test: blood sample collection

Interventions

blood sample collection by venipuncture four both groups and MRI for breast cancr patient group

Second group (breast cancer patient group)first group (control group)

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

females 18 years old or above

You may qualify if:

  • control group of normal healthy individuals who don't have tumors in other organs.
  • breast cancer group Patients with confirmed breast cancer who didn't receive radiotherapy ,chemotherapy ,hormonal therapy or surgical treatment.

You may not qualify if:

  • Patients refuse to be part of study and undergo examination .
  • All patients with breast cancer that had received chemotherapy, radiotherapy , ,hormonal or surgical treatment.
  • History of benign or malignant tumors in other organs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

    PMID: 30207593BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

blood sample by veinpuncture prosedure into EDITA tubes

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Asmaa Abdelghfour

CONTACT

Tahia Hashim Saleem

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
demonstrator

Study Record Dates

First Submitted

February 25, 2021

First Posted

March 2, 2021

Study Start

March 1, 2022

Primary Completion

March 1, 2023

Study Completion

March 1, 2024

Last Updated

March 8, 2021

Record last verified: 2021-03