Aberrant Expression of Micro RNA for Diagnosis of Breast Cancer

January 21, 2021 updated by: Hosam Atif Sayed Anas, Assiut University

Aberrant Expression of Circulating Micro RNA as a Biomarker for Diagnosis of Breast Cancer in Egyptian Females

In this study we aim to:

  1. Assess serum miRNA-373, miRNA-425-5p expression in patients with breast cancer.
  2. Explore their correlations with breast cancer clinicopathological documented data including staging, grading and tumor receptors.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Breast cancer (BC) is the leading cause of cancer worldwide with estimated 2.3 million new cases and 685000 deaths in 2020. In women, breast cancer accounts for one in 4 cancer cases and one in 6 cancer deaths.

In Egypt, BC is the most common cancer among females accounting for 32.0% of all cancers in women according to the data of the National Cancer Registry Program of Egypt . 22038 Egyptian females breast cancer new cases were estimated to be in 2020 .

The most important risk factors for breast cancer include female gender, age (30 years old and older), positive family history for breast cancer , and familial genetic mutations, including mutations in the breast cancer A1 (BRCA1) and BRCA2 genes. Furthermore, women with a history of breast cancer are more likely (20-25%) to develop microscopic cancer in the opposite breast. A positive history for cancer in the endometrium, ovaries, or colon, as well as radiation therapy for Hodgkin's lymphoma, was shown to increase the risk of breast cancer.

The gold standard for diagnosis of breast cancer is histopathology. Several tumor markers have been suggested for the evaluation and management of breast cancer including estrogen and progesterone receptors (ER/PR), which are used for the assessment of susceptibility to hormone treatment, and human epidermal growth factor receptor 2 (HER2), which is used to assess the susceptibility to trastuzumab treatment.

With the rapid development of medical technology, strategies such as surgery, medication and radiotherapy can help a lot to reduce mortality rate. Though clinical intervention at early stage can greatly improve prognosis, many BC patients are asymptomatic until disease progression.

Thus, effective screening methods are in great demand for the early detection of BC. In clinical practice, many screening strategies have been widely used, such as mammography, breast magnetic resonance imaging (MRI) and ultrasound imaging.

However, these strategies are far from being perfect because of over-diagnosis, false-positive inconsistent results and potential radiation injury.

Core needle aspiration can help establish the diagnosis, but the procedure is invasive and not suitable for routine use .

Therefore, novel non-invasive screening methods of high sensitivity and specificity are needed to assist the early diagnosis of BC .

Microribonucleic Acids (microRNAs) are a large subgroup of noncoding RNAs made up of 18-25 nucleotides. MicroRNAs regulate gene expression after transcription. They have a multifunctional role, as they can perform either as oncogenes by repressing their target tumor suppressor genes, or as tumor suppressors through inhibiting the expression of their target oncogenes.

Numerous studies have shown that miRNAs played important roles in nearly all biological processes and their aberrant expression was associated with many diseases including cancers. Stable existence of miRNAs in peripheral blood circulation revealed that they could be promising noninvasive biomarkers for cancer detection.

For BC, more and more circulating miRNAs (ie, miRNA-373, miRNA-425-5p) are emerging as potential diagnostic or prognostic biomarkers.

In breast cancer miRNA-425-5p was found elevated and predicted a poor prognosis for the patients, and its role in BC highlight a new research points for diagnostic and therapeutic plans.

MiRNA-373 Circulating level has been reported as a potential biomarker of lymph node metastasis and its expression has been linked to promoting migration and invasion of breast cancer cells. It has also been reported that correlations between decreased miRNA-373 expression and BC relapse.

However, findings often differed from each other due to different experiment design, study cohorts or disease status.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

This is a case control hospital-based study will conduct on women divided into two groups:

Group A (patient group) : included patients with BC admitted to department of medical Oncology, South Egypt Cancer Institute, Assiut University. Whereas,

Group B (control group) : included controls age-matched , sex-matched and apparently healthy.

Description

Inclusion Criteria:

  • Female age 20 years or older
  • documented diagnosis of breast cancer based on physical examination, imaging and histopathology
  • possibility of obtaining blood samples from the subject.

Exclusion Criteria:

  • All patients with prior history of exposure to chemotherapy, radiotherapy or hormonal therapy .
  • patients with other malignancies.
  • patients with chronic inflammatory diseases.
  • patients with missed documentation for histopathological diagnosis of breast cancer.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A (patient group)

included 25 patients with BC admitted to department of medical Oncology, South Egypt Cancer Institute, Assiut University.

blood samples will be obtained after getting informed consent.
Diagnostic test: blood sample collection.
venipuncture procedure
Group B (control group)
included 25 controls age-matched , sex-matched and apparently healthy. blood samples will be obtained after getting informed consent .
Diagnostic test: blood sample collection.
venipuncture procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess serum miRNA-373 and miRNA-425-5p expression in patients with breast cancer.
Time Frame: baseline
compare level of serum miRNA-373 and miRNA-425-5p expression in breast cancer patients with that of normal control in aim to help in diagnosis of BC patients and staging them
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Explore correlations of serum miRNA-373 and miRNA-425-5p expression in breast cancer patients with clinicopathological documented data including staging, grading and tumor receptors.
Time Frame: baseline
aim to find significant correlations help in future diagnosis and treatment .
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2021

Primary Completion (Anticipated)

October 25, 2023

Study Completion (Anticipated)

December 25, 2023

Study Registration Dates

First Submitted

January 19, 2021

First Submitted That Met QC Criteria

January 21, 2021

First Posted (Actual)

January 22, 2021

Study Record Updates

Last Update Posted (Actual)

January 22, 2021

Last Update Submitted That Met QC Criteria

January 21, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • miRNA in breast cancer

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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