Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04778202
Status:
UNKNOWN
Last Update Posted:
2021-03-08
First Post:
2021-02-25
Brief Title:
Diagnostic and Prognostic Value of MicroRNA in Breast Cancer Patients
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Diagnostic and Prognostic Value of MicroRNA as a Potential Biomarker in Breast Cancer Patients in Correlation to Radiological Findings
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Australias 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 treatmentapproximately 20 of BC patients will develop metastasisThis 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
Despite the improvement in diagnosis and treatmentapproximately 20 of BC patients will develop metastasisThis 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None