Breast CancerNCT04778202
Diagnostic and Prognostic Value of MicroRNA in Breast Cancer Patients
An observational study of Breast Cancer, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- blood sample collection
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2022to 1 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Adult, Older adult
Study population: females 18 years old or above
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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
- Conditions
- Breast Cancer
- Being tested
- blood sample collection
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sample collectionDiagnostic test
blood sample collection by venipuncture four both groups and MRI for breast cancr patient group
| Study group | Role | What they receive |
|---|---|---|
| first group (control group) | 25 normal health control women apparently healthy. blood samples will be obtained after getting informed consent Receives: 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 Receives: Diagnostic Test: blood sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 18-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2021
- Study start1 Mar 2022 (estimated)
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, asmaa saleh abdelghfour, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04778202
- Sponsor's protocol ID
- MicroRNA in breast cancer
- Status last verified
- Mar 2021
- First submitted
- 25 Feb 2021
- Last updated
- 8 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30207593
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic and Prognostic Value of MicroRNA as a Potential Biomarker in Breast Cancer Patients in Correlation to Radiological Findings.
- ClinicalTrials.gov ID
- NCT04778202
- Acronym / sponsor ID
- MicroRNA in breast cancer
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (estimated)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 2 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| first group (control group) | – | Diagnostic Test: blood sample collection25 normal health control women apparently healthy. blood samples will be obtained after getting informed consent |
| Second group (breast cancer patient group) | – | Diagnostic Test: blood sample collection25 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- females 18 years old or above
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sample collectionblood sample collection by venipuncture four both groups and MRI for breast cancr patient group | Diagnostic test | Second group (breast cancer patient group), first group (control group) |
Primary outcome
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
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
- Background: PubMed 30207593Bray 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asmaa Abdelghfour (01114081316, asmaasalh104@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of the value of MiRNA in diagnosis and prognosis of breast cancer patients (time frame: 18-24 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04778202, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2021.