Breast CancerNCT04720508
Aberrant Expression of Micro RNA for Diagnosis of Breast Cancer
An observational study of Breast Cancer, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and older, 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 Dec 2021to 25 Dec 2023
- 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 20 years and older
- Women only
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Aberrant Expression of Circulating Micro RNA as a Biomarker for Diagnosis of Breast Cancer in Egyptian Females
In this study we aim to:
- Assess serum miRNA-373, miRNA-425-5p expression in patients with breast cancer.
- Explore their correlations with breast cancer clinicopathological documented data including staging, grading and tumor receptors.
Read the 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.
- 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 collection.Diagnostic test
venipuncture procedure
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: blood sample collection. | |
| Group B (control group) | included 25 controls age-matched , sex-matched and apparently healthy. blood samples will be obtained after getting informed consent . Receives: Diagnostic Test: blood sample collection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess serum miRNA-373 and miRNA-425-5p expression in patients with breast cancer.
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
Measured: baseline
Secondary outcomes (1)
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.
aim to find significant correlations help in future diagnosis and treatment .
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Dec 2021 (estimated)
- Primary completion25 Oct 2023 (estimated)
- Study completion25 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)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
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hosam Atif Sayed Anas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04720508
- Sponsor's protocol ID
- miRNA in breast cancer
- Status last verified
- Jan 2021
- First submitted
- 19 Jan 2021
- Last updated
- 22 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ibrahim AS, Khaled HM, Mikhail NN, Baraka H, Kamel H. Cancer incidence in egypt: results of the national population-based cancer registry program. J Cancer Epidemiol. 2014;2014:437971. doi: 10.1155/2014/437971. Epub 2014 Sep 21.
PubMed 25328522Yalcin B. Staging, risk assessment and screening of breast cancer. Exp Oncol. 2013 Dec;35(4):238-45.
PubMed 24382431Autier P, Boniol M. Mammography screening: A major issue in medicine. Eur J Cancer. 2018 Feb;90:34-62. doi: 10.1016/j.ejca.2017.11.002. Epub 2017 Dec 20.
PubMed 29272783Matsen CB, Neumayer LA. Breast cancer: a review for the general surgeon. JAMA Surg. 2013 Oct;148(10):971-9. doi: 10.1001/jamasurg.2013.3393.
PubMed 23986370Aalami AH, Pouresmaeil V, Amirabadi A, Mojahed FH, Rad MQ, Sahebkar A. Evaluation of the Diagnostic Properties of Serum hsa-miR-223-5p in the Detection of Gastric Cancer: A Case-Control Study. Anticancer Agents Med Chem. 2020;20(7):800-808. doi: 10.2174/1871520620666200204100602.
PubMed 32013852Zhou Y, Sheng B, Xia Q, Guan X, Zhang Y. Association of long non-coding RNA H19 and microRNA-21 expression with the biological features and prognosis of non-small cell lung cancer. Cancer Gene Ther. 2017 Aug;24(8):317-324. doi: 10.1038/cgt.2017.20. Epub 2017 Aug 11.
PubMed 28799568Eichelser C, Flesch-Janys D, Chang-Claude J, Pantel K, Schwarzenbach H. Deregulated serum concentrations of circulating cell-free microRNAs miR-17, miR-34a, miR-155, and miR-373 in human breast cancer development and progression. Clin Chem. 2013 Oct;59(10):1489-96. doi: 10.1373/clinchem.2013.205161. Epub 2013 Jun 7.
PubMed 23748853Mangolini A, Ferracin M, Zanzi MV, Saccenti E, Ebnaof SO, Poma VV, Sanz JM, Passaro A, Pedriali M, Frassoldati A, Querzoli P, Sabbioni S, Carcoforo P, Hollingsworth A, Negrini M. Diagnostic and prognostic microRNAs in the serum of breast cancer patients measured by droplet digital PCR. Biomark Res. 2015 Jun 6;3:12. doi: 10.1186/s40364-015-0037-0. eCollection 2015.
PubMed 26120471Zhang LF, Zhang JG, Zhou H, Dai TT, Guo FB, Xu SY, Chen Y. MicroRNA-425-5p promotes breast cancer cell growth by inducing PI3K/AKT signaling. Kaohsiung J Med Sci. 2020 Apr;36(4):250-256. doi: 10.1002/kjm2.12148. Epub 2019 Nov 5.
PubMed 31688991Huang Q, Gumireddy K, Schrier M, le Sage C, Nagel R, Nair S, Egan DA, Li A, Huang G, Klein-Szanto AJ, Gimotty PA, Katsaros D, Coukos G, Zhang L, Pure E, Agami R. The microRNAs miR-373 and miR-520c promote tumour invasion and metastasis. Nat Cell Biol. 2008 Feb;10(2):202-10. doi: 10.1038/ncb1681. Epub 2008 Jan 13.
PubMed 18193036Inns J, James V. Circulating microRNAs for the prediction of metastasis in breast cancer patients diagnosed with early stage disease. Breast. 2015 Aug;24(4):364-9. doi: 10.1016/j.breast.2015.04.001. Epub 2015 May 6.
PubMed 25957467Pimentel F, Bonilla P, Ravishankar YG, Contag A, Gopal N, LaCour S, Lee T, Niemz A. Technology in MicroRNA Profiling: Circulating MicroRNAs as Noninvasive Cancer Biomarkers in Breast Cancer. J Lab Autom. 2015 Oct;20(5):574-88. doi: 10.1177/2211068214561788. Epub 2014 Dec 18.
PubMed 25524488Hosseini Mojahed F, Aalami AH, Pouresmaeil V, Amirabadi A, Qasemi Rad M, Sahebkar A. Clinical Evaluation of the Diagnostic Role of MicroRNA-155 in Breast Cancer. Int J Genomics. 2020 Sep 7;2020:9514831. doi: 10.1155/2020/9514831. eCollection 2020.
PubMed 32964011Swellam M, El Magdoub HM, Hassan NM, Hefny MM, Sobeih ME. Potential diagnostic role of circulating MiRNAs in breast cancer: Implications on clinicopathological characters. Clin Biochem. 2018 Jun;56:47-54. doi: 10.1016/j.clinbiochem.2018.04.013. Epub 2018 Apr 19.
PubMed 29679553
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aberrant Expression of Circulating Micro RNA as a Biomarker for Diagnosis of Breast Cancer in Egyptian Females
- ClinicalTrials.gov ID
- NCT04720508
- Acronym / sponsor ID
- miRNA 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 Dec 2021 (estimated)
- Primary completion
- 25 Oct 2023 (estimated)
- Study completion
- 25 Dec 2023 (estimated)
- First posted
- 22 Jan 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.
In this study we aim to:
- Assess serum miRNA-373, miRNA-425-5p expression in patients with breast cancer.
- Explore their correlations with breast cancer clinicopathological documented data including staging, grading and tumor receptors.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (patient group) | – | Diagnostic Test: blood sample collection.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. |
| Group B (control group) | – | Diagnostic Test: blood sample collection.included 25 controls age-matched , sex-matched and apparently healthy. blood samples will be obtained after getting informed consent . |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 collection.venipuncture procedure | Diagnostic test | Group A (patient group), Group B (control group) |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Background: PubMed 25328522Ibrahim AS, Khaled HM, Mikhail NN, Baraka H, Kamel H. Cancer incidence in egypt: results of the national population-based cancer registry program. J Cancer Epidemiol. 2014;2014:437971. doi: 10.1155/2014/437971. Epub 2014 Sep 21.
- Background: PubMed 24382431Yalcin B. Staging, risk assessment and screening of breast cancer. Exp Oncol. 2013 Dec;35(4):238-45.
- Background: PubMed 29272783Autier P, Boniol M. Mammography screening: A major issue in medicine. Eur J Cancer. 2018 Feb;90:34-62. doi: 10.1016/j.ejca.2017.11.002. Epub 2017 Dec 20.
- Background: PubMed 23986370Matsen CB, Neumayer LA. Breast cancer: a review for the general surgeon. JAMA Surg. 2013 Oct;148(10):971-9. doi: 10.1001/jamasurg.2013.3393.
- Background: PubMed 32013852Aalami AH, Pouresmaeil V, Amirabadi A, Mojahed FH, Rad MQ, Sahebkar A. Evaluation of the Diagnostic Properties of Serum hsa-miR-223-5p in the Detection of Gastric Cancer: A Case-Control Study. Anticancer Agents Med Chem. 2020;20(7):800-808. doi: 10.2174/1871520620666200204100602.
- Background: PubMed 28799568Zhou Y, Sheng B, Xia Q, Guan X, Zhang Y. Association of long non-coding RNA H19 and microRNA-21 expression with the biological features and prognosis of non-small cell lung cancer. Cancer Gene Ther. 2017 Aug;24(8):317-324. doi: 10.1038/cgt.2017.20. Epub 2017 Aug 11.
- Background: PubMed 23748853Eichelser C, Flesch-Janys D, Chang-Claude J, Pantel K, Schwarzenbach H. Deregulated serum concentrations of circulating cell-free microRNAs miR-17, miR-34a, miR-155, and miR-373 in human breast cancer development and progression. Clin Chem. 2013 Oct;59(10):1489-96. doi: 10.1373/clinchem.2013.205161. Epub 2013 Jun 7.
- Background: PubMed 26120471Mangolini A, Ferracin M, Zanzi MV, Saccenti E, Ebnaof SO, Poma VV, Sanz JM, Passaro A, Pedriali M, Frassoldati A, Querzoli P, Sabbioni S, Carcoforo P, Hollingsworth A, Negrini M. Diagnostic and prognostic microRNAs in the serum of breast cancer patients measured by droplet digital PCR. Biomark Res. 2015 Jun 6;3:12. doi: 10.1186/s40364-015-0037-0. eCollection 2015.
- Background: PubMed 31688991Zhang LF, Zhang JG, Zhou H, Dai TT, Guo FB, Xu SY, Chen Y. MicroRNA-425-5p promotes breast cancer cell growth by inducing PI3K/AKT signaling. Kaohsiung J Med Sci. 2020 Apr;36(4):250-256. doi: 10.1002/kjm2.12148. Epub 2019 Nov 5.
- Background: PubMed 18193036Huang Q, Gumireddy K, Schrier M, le Sage C, Nagel R, Nair S, Egan DA, Li A, Huang G, Klein-Szanto AJ, Gimotty PA, Katsaros D, Coukos G, Zhang L, Pure E, Agami R. The microRNAs miR-373 and miR-520c promote tumour invasion and metastasis. Nat Cell Biol. 2008 Feb;10(2):202-10. doi: 10.1038/ncb1681. Epub 2008 Jan 13.
- Background: PubMed 25957467Inns J, James V. Circulating microRNAs for the prediction of metastasis in breast cancer patients diagnosed with early stage disease. Breast. 2015 Aug;24(4):364-9. doi: 10.1016/j.breast.2015.04.001. Epub 2015 May 6.
- Background: PubMed 25524488Pimentel F, Bonilla P, Ravishankar YG, Contag A, Gopal N, LaCour S, Lee T, Niemz A. Technology in MicroRNA Profiling: Circulating MicroRNAs as Noninvasive Cancer Biomarkers in Breast Cancer. J Lab Autom. 2015 Oct;20(5):574-88. doi: 10.1177/2211068214561788. Epub 2014 Dec 18.
- The Global Cancer ObservatoryLink provided by the sponsor.
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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 3 inclusion and 4 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 22 Jan 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 Hosam Atif Anas (01113483821, hosamanas94@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess serum miRNA-373 and miRNA-425-5p expression in patients with breast cancer. (time frame: baseline). 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 NCT04720508, which also lists 14 linked publications.
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 22 Jan 2021.