Diagnostic and Prognostic Value of MicroRNA in Breast Cancer Patients

March 4, 2021 updated by: asmaa saleh abdelghfour, Assiut University

Diagnostic and Prognostic Value of MicroRNA as a Potential Biomarker in Breast Cancer Patients in Correlation to Radiological Findings.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Breast cancer ( BC) is the most commonly diagnosed cancer in women worldwide. The incidence and mortality rates for female breast cancer far exceeded those for other cancers . Although the incidence rate of breast cancer has risen, the mortality rates have steadily fallen due to early diagnosis and better treatments . Early detection of breast cancer often leads to better outcomes. According to Cancer Australia's National Cancer Control Indicators, the relative survival for females diagnosed with early-stage breast cancers at diagnosis was much higher than that for those with advanced breast diagnosis.

Despite the improvement in diagnosis and treatment,approximately 20% of BC patients will develop metastasis.This setting is considered an incurable disease that often occurs due to either resistance to therapy or diagnosis at advanced stages . In this scenario, although 44% of the patients are diagnosed at stage I (AJCC cancer staging) with 5-year survival rates of 100%, 5% of patients are diagnosed at stage IV with 5-year survival rates of approximately 26% .

The small percentage of women diagnosed at advanced stage of the disease gives evidence that mammography represents the best available screening option for breast cancer .

However, more accurate and meaningful early-diagnosis methods together with image techniques would improve BC survival rates.

MicroRNAs (MiRNAs) are short endogenous noncoding RNA molecules of 19-25 nt that have important gene regulatory roles at post-transcriptional level [8, 9]. They pair with messenger RNAs (mRNAs) of protein-coding genes and depending on complementarity, leading to mRNa translational repression or degradation . They regulate 30% of transcripts and contain 3% of the human genome .

In the past few years, miRNAs were established as relevant molecular components of cells in normal or malignant processes.. Particularly, miRNAs have been demonstrated to have an important role in cancer biology through post transcriptional editing of target messenger RNAs expression involved in tumor growth, invasion, metastasis or immune escape .

In addition, several tumor-associated miRNA profiles have been proposed and investigated as biomarkers for diagnosis, survival, response to treatment or tumor subclassification.

The development of early diagnostic tools is of most interest to the clinics since early diagnosis is associated with better prognosis.

In this context, miRNAs have been demonstrated to be good early diagnostic biomarkers in several types of cancer including BC, among others.

One of the main advantages of circulating miRNAs is their high stability in body fluids , which is the main reason for them to be used in cancer diagnosis or prognosis.

Moreover, the assessment of circulating miRNAs can be carried out with simple, lowcost and quick assays.

These characteristics highlight the value of miRNAs as non-invasive biomarkers. Indeed, several miRNAs have been found to be differentially expressed in blood, plasma or serum from healthy donors compared with BC patients, supporting their use as noninvasive, early-stage diagnosis biomarkers.

Growing evidences revealed that imaging techniques are associated with some limitations such as expensive. Hence, it seems that utilization of improvement imaging techniques and biochemistry biomarkers could overcome the limitations associated with imaging techniques. Beside utilization of imaging techniques, identification of new biomarkers in patients with breast cancer has provided an interesting landscape .

So studies have identified different circulating miRNAs as new biomarkers for BC detection; Moreover, they have not been assessed in conjunction with diagnostic imaging, which is used for quantifying the extent of the disease and provides information related to tumour aggressiveness representing an obligatory step for treatment planning. The use of diagnostic imaging to extract quantitative parameters related to the morphology, metabolism and functionality of tumours, as well as to correlate specific imaging parameters with molecular biomarkers, is an emerging research topic

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

females 18 years old or above

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
blood sample collection by venipuncture four both groups and MRI for breast cancr patient group
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
blood sample collection by venipuncture four both groups and MRI for breast cancr patient group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assessment of the value of MiRNA in diagnosis and prognosis of breast cancer patients
Time Frame: 18-24 month
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
Time Frame: 18-24 months
Also trying to correlate the results with MRI radiological findings which may help in better selection of treatment protocols.
18-24 months

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

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)

March 1, 2022

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

February 25, 2021

First Submitted That Met QC Criteria

February 26, 2021

First Posted (Actual)

March 2, 2021

Study Record Updates

Last Update Posted (Actual)

March 8, 2021

Last Update Submitted That Met QC Criteria

March 4, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MicroRNA 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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