Breast CarcinomaNCT05151224
Circulating microRNA 21 Expression Level Before and After Neoadjuvant Systemic Therapy in Breast Carcinoma
An observational study of Breast Carcinoma, run by Ain Shams University at 1 site in Egypt.
Trial summary
MicroRNAs (miRNAs) are involved in the development and progression of malignant tumors. In breast cancer, differential miRNA expression has been demonstrated across breast cancer subtypes, with both tumor-promoting and tumor suppressive functions for individual miRNAs. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Carcinoma
- What is being tested?
- microRNA 21
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2021to Jan 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Invasive breast cancer, from stage IIB to stage IIIC, all subtypes are included, who are candidates for neoadjuvant systemic therapy.
Who may be able to join
- Age >/= 18 years old.
- Breast cancer diagnosis histologically proven and pathology report from breast and ipsilateral axillary nodes.
- Pathology: invasive carcinoma.
- Staging: tumor size >2cm (>/=T2), node positive (N >/= 1), i.e. >/= T2N1; from stage IIB to stage IIIC, according to AJCC breast Cancer staging 8th edition. (Giuliano, Edge and Hortobagyi, 2018)
- All subtypes are included, either HR (ER, PR) positive or negative, HER2 positive or negative.
- Neoadjuvant systemic treatment composed of anthracyclines-based chemotherapy and taxanes, trastuzumab for HER2 positive patients
Who cannot join
- Metastatic breast cancer
- inflammatory breast cancer,
- male breast cancer,
- bilateral breast cancer, or concurrent malignancy
- Previous malignancy.
- Presence of any contraindication to neoadjuvant treatment
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Ain Shams University Hospitals
Cairo
Ebtehal M Salah, ebtehal.mohamed@hotmail.com
About this study
MicroRNAs (miRNAs) are involved in the development and progression of malignant tumors. In breast cancer, differential miRNA expression has been demonstrated across breast cancer subtypes, with both tumor-promoting and tumor suppressive functions for individual miRNAs.
Novel predictive biomarkers that can be assessed in the liquid specimen before systemic treatment could help to individualize treatment decisions in breast cancer and to potentially avoid ineffective systemic treatment.
In our study we detect level of circulating miRNA 21 in breast cancer patient before and after neoadjuvant treatment , whether there will be change or not, and if related to complete pathological response.
Read the detailed description
MicroRNAs (miRNAs) are a group of non-coding, single stranded RNAs of ~ 19-24 nucleotides, which act by a novel mechanism of posttranscriptional regulation that is profoundly altered in malignant cells. (Ling, Fabbri and Calin, 2013).Based on the function of miRNAs, they are divided into two types: an oncomir, implicated in cancer progression by regulating tumor suppressor genes negatively; and a tumor suppressor, preventing cancers by regulating oncogenes. (Zhang et al., 2007).
A key oncomir in carcinogenesis is miRNA-21, which was one of the first miRNAs detected in the human genome. It is located on chromosome 17 in the tenth intron of the coding gene transmembrane protein 49, which targets various tumor suppressors like PTEN, PDCD4, p53, and TAp63 pathways. (Yadav et al., 2016)
Experimental and literature research has highlighted that miRNA-21 was always significantly elevated in every study that included invasive breast carcinomas compared with healthy breast tissue. (Petrović, 2016).
miRNA-21 has been shown to be a very important promoter of cellular outgrowth, migration, invasion, and metastasis. In breast carcinoma cell lines, miRNA-21 was connected to cell proliferation and migration. (Yan et al., 2011).
Mei and her colleagues (2010) reported that miRNA-21 up-regulation is associated with therapy (taxol) resistance in breast cancer cells and further validated in a recent study by (Chen and Bourguignon, 2014) in which miRNA-21 up-regulation resulted in an increase of anti-apoptosis protein BCL-2 and chemo-resistance in breast cancer cells
Various studies have supported the potential role of circulating miRNAs to be used as prognostic and predictor biomarkers in breast cancer. (Schwarzenbach, 2017)
In their analysis of the blood serum of 56 breast cancer patients, Wang et al. (2012) illustrate reduced miR-125b levels to correlate with resistance to four cycles of neoadjuvant 5-fluorouracil, epirubicin and cyclophosphamide (FEC). Another recent study investigating dynamic changes of circulating miRNA as indicator for clinical response for neoadjuvant chemotherapy in HER2 negative patients , found that dynamics of three plasma miRNA , including miRNA 222, miRNA 20-a and miRNA 451 was associated with chemosensitivity. (Zhu et al., 2018)
The expression of serum-miRNA-125b and the changes of serum miRNA-21 expression during neoadjuvant chemotherapy were associated with chemotherapy response and disease-free survival (DFS). (Liu et al., 2017). Yadav et al. (2016) found that breast cancer patients received neoadjuvant therapy shows significant impact on overall reduction in serum miRNA-21 expression compared to before therapy (p < 0.0001)
- Conditions
- Breast Carcinoma
- Being tested
- microRNA 21
- Keywords
- breast, microRNA 21, Neoadjuvant thera[py
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microRNA 21Diagnostic test
Plasma microRNA 21 5p expression, by real-time polymerase chain reaction, before and after neoadjuvant systemic therapy.
Blood sample will be taken by a trained nurse, amount of blood will be 3 ml, and will be taken twice, one time before the start of the neoadjuvant systemic treatment , second time by the end of the neoadjuvant systemic treatment.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer patients eligible to neoadjuvant systemic therapy | Invasive breast cancer, age are 18 years or more, from stage IIB to stage IIIC, all subtypes are included, either HR (ER, PR) positive or negative, HER2 positive or negative, eligible to neoadjuvant systemic therapy. Receives: Diagnostic Test: microRNA 21 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe miRNA 21 expression level before and after neoadjuvant systemic therapy in breast cancer patient.
miRNA 21 expression level before and after neoadjuvant systemic therapy
Measured: 1 year
Secondary outcomes (2)
Measure relation between miRNA 21 expression level before and after neoadjuvant systemic therapy and pathological response.
Relation between miRNA 21 expression level before and after neoadjuvant systemic therapy and pathological response
Measured: 1 year
Measure relation between the miRNA 21 expression and the clinicopathological parameters of Breast Cancer patients.
Relation between the miRNA 21 expression and the clinicopathological parameters
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study startDec 2021 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebtehal Mohamed Mahmoud Salah, Ain Shams University
- Investigators
- Ebtehal M Salah, Principal investigator, Assistant lecturer of clinical oncologyIman Sharawy, Study director, Professor of clinical oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05151224
- Sponsor's protocol ID
- FMASUMD232/2021
- Status last verified
- Nov 2021
- First submitted
- 27 Nov 2021
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mei M, Ren Y, Zhou X, Yuan XB, Han L, Wang GX, Jia Z, Pu PY, Kang CS, Yao Z. Downregulation of miR-21 enhances chemotherapeutic effect of taxol in breast carcinoma cells. Technol Cancer Res Treat. 2010 Feb;9(1):77-86. doi: 10.1177/153303461000900109.
PubMed 20082533Yadav P, Mirza M, Nandi K, Jain SK, Kaza RC, Khurana N, Ray PC, Saxena A. Serum microRNA-21 expression as a prognostic and therapeutic biomarker for breast cancer patients. Tumour Biol. 2016 Nov;37(11):15275-15282. doi: 10.1007/s13277-016-5361-y. Epub 2016 Sep 30.
PubMed 27696295Ling H, Fabbri M, Calin GA. MicroRNAs and other non-coding RNAs as targets for anticancer drug development. Nat Rev Drug Discov. 2013 Nov;12(11):847-65. doi: 10.1038/nrd4140.
PubMed 24172333Zhang B, Pan X, Cobb GP, Anderson TA. microRNAs as oncogenes and tumor suppressors. Dev Biol. 2007 Feb 1;302(1):1-12. doi: 10.1016/j.ydbio.2006.08.028. Epub 2006 Aug 16.
PubMed 16989803Petrovic N. miR-21 Might be Involved in Breast Cancer Promotion and Invasion Rather than in Initial Events of Breast Cancer Development. Mol Diagn Ther. 2016 Apr;20(2):97-110. doi: 10.1007/s40291-016-0186-3.
PubMed 26891730Yan LX, Wu QN, Zhang Y, Li YY, Liao DZ, Hou JH, Fu J, Zeng MS, Yun JP, Wu QL, Zeng YX, Shao JY. Knockdown of miR-21 in human breast cancer cell lines inhibits proliferation, in vitro migration and in vivo tumor growth. Breast Cancer Res. 2011 Jan 10;13(1):R2. doi: 10.1186/bcr2803.
PubMed 21219636Chen L, Bourguignon LY. Hyaluronan-CD44 interaction promotes c-Jun signaling and miRNA21 expression leading to Bcl-2 expression and chemoresistance in breast cancer cells. Mol Cancer. 2014 Mar 8;13:52. doi: 10.1186/1476-4598-13-52.
PubMed 24606718Schwarzenbach H. Clinical Relevance of Circulating, Cell-Free and Exosomal microRNAs in Plasma and Serum of Breast Cancer Patients. Oncol Res Treat. 2017;40(7-8):423-429. doi: 10.1159/000478019. Epub 2017 Jun 28.
PubMed 28683441Zhu W, Liu M, Fan Y, Ma F, Xu N, Xu B. Dynamics of circulating microRNAs as a novel indicator of clinical response to neoadjuvant chemotherapy in breast cancer. Cancer Med. 2018 Sep;7(9):4420-4433. doi: 10.1002/cam4.1723. Epub 2018 Aug 11.
PubMed 30099860Wang H, Tan G, Dong L, Cheng L, Li K, Wang Z, Luo H. Circulating MiR-125b as a marker predicting chemoresistance in breast cancer. PLoS One. 2012;7(4):e34210. doi: 10.1371/journal.pone.0034210. Epub 2012 Apr 16.
PubMed 22523546Liu B, Su F, Chen M, Li Y, Qi X, Xiao J, Li X, Liu X, Liang W, Zhang Y, Zhang J. Serum miR-21 and miR-125b as markers predicting neoadjuvant chemotherapy response and prognosis in stage II/III breast cancer. Hum Pathol. 2017 Jun;64:44-52. doi: 10.1016/j.humpath.2017.03.016. Epub 2017 Apr 12.
PubMed 28412211
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating microRNA 21 Expression Level Before and After Neoadjuvant Systemic Therapy in Breast Carcinoma
- ClinicalTrials.gov ID
- NCT05151224
- Acronym / sponsor ID
- FMASUMD232/2021
- Conditions
- Breast Carcinoma
- Keywords
- breast, microRNA 21, Neoadjuvant thera[py
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Dec 2021 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 9 Dec 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.
MicroRNAs (miRNAs) are involved in the development and progression of malignant tumors. In breast cancer, differential miRNA expression has been demonstrated across breast cancer subtypes, with both tumor-promoting and tumor suppressive functions for individual miRNAs.
Novel predictive biomarkers that can be assessed in the liquid specimen before systemic treatment could help to individualize treatment decisions in breast cancer and to potentially avoid ineffective systemic treatment.
In our study we detect level of circulating miRNA 21 in breast cancer patient before and after neoadjuvant treatment , whether there will be change or not, and if related to complete pathological response.
Detailed description
MicroRNAs (miRNAs) are a group of non-coding, single stranded RNAs of ~ 19-24 nucleotides, which act by a novel mechanism of posttranscriptional regulation that is profoundly altered in malignant cells. (Ling, Fabbri and Calin, 2013).Based on the function of miRNAs, they are divided into two types: an oncomir, implicated in cancer progression by regulating tumor suppressor genes negatively; and a tumor suppressor, preventing cancers by regulating oncogenes. (Zhang et al., 2007).
A key oncomir in carcinogenesis is miRNA-21, which was one of the first miRNAs detected in the human genome. It is located on chromosome 17 in the tenth intron of the coding gene transmembrane protein 49, which targets various tumor suppressors like PTEN, PDCD4, p53, and TAp63 pathways. (Yadav et al., 2016)
Experimental and literature research has highlighted that miRNA-21 was always significantly elevated in every study that included invasive breast carcinomas compared with healthy breast tissue. (Petrović, 2016).
miRNA-21 has been shown to be a very important promoter of cellular outgrowth, migration, invasion, and metastasis. In breast carcinoma cell lines, miRNA-21 was connected to cell proliferation and migration. (Yan et al., 2011).
Mei and her colleagues (2010) reported that miRNA-21 up-regulation is associated with therapy (taxol) resistance in breast cancer cells and further validated in a recent study by (Chen and Bourguignon, 2014) in which miRNA-21 up-regulation resulted in an increase of anti-apoptosis protein BCL-2 and chemo-resistance in breast cancer cells
Various studies have supported the potential role of circulating miRNAs to be used as prognostic and predictor biomarkers in breast cancer. (Schwarzenbach, 2017)
In their analysis of the blood serum of 56 breast cancer patients, Wang et al. (2012) illustrate reduced miR-125b levels to correlate with resistance to four cycles of neoadjuvant 5-fluorouracil, epirubicin and cyclophosphamide (FEC). Another recent study investigating dynamic changes of circulating miRNA as indicator for clinical response for neoadjuvant chemotherapy in HER2 negative patients , found that dynamics of three plasma miRNA , including miRNA 222, miRNA 20-a and miRNA 451 was associated with chemosensitivity. (Zhu et al., 2018)
The expression of serum-miRNA-125b and the changes of serum miRNA-21 expression during neoadjuvant chemotherapy were associated with chemotherapy response and disease-free survival (DFS). (Liu et al., 2017). Yadav et al. (2016) found that breast cancer patients received neoadjuvant therapy shows significant impact on overall reduction in serum miRNA-21 expression compared to before therapy (p < 0.0001)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer patients eligible to neoadjuvant systemic therapy | – | Diagnostic Test: microRNA 21Invasive breast cancer, age are 18 years or more, from stage IIB to stage IIIC, all subtypes are included, either HR (ER, PR) positive or negative, HER2 positive or negative, eligible to neoadjuvant systemic therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Invasive breast cancer, from stage IIB to stage IIIC, all subtypes are included, who are candidates for neoadjuvant systemic therapy.
Key inclusion criteria (6 listed)
- Age >/= 18 years old.
- Breast cancer diagnosis histologically proven and pathology report from breast and ipsilateral axillary nodes.
- Pathology: invasive carcinoma.
- Staging: tumor size >2cm (>/=T2), node positive (N >/= 1), i.e. >/= T2N1; from stage IIB to stage IIIC, according to AJCC breast Cancer staging 8th edition. (Giuliano, Edge and Hortobagyi, 2018)
- All subtypes are included, either HR (ER, PR) positive or negative, HER2 positive or negative.
Key exclusion criteria (6 listed)
- Metastatic breast cancer
- inflammatory breast cancer,
- male breast cancer,
- bilateral breast cancer, or concurrent malignancy
- Previous malignancy.
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 |
|---|---|---|
| microRNA 21Plasma microRNA 21 5p expression, by real-time polymerase chain reaction, before and after neoadjuvant systemic therapy. Blood sample will be taken by a trained nurse, amount of blood will be 3 ml, and will be taken twice, one time before the start of the neoadjuvant systemic treatment , second time by the end of the neoadjuvant systemic treatment. | Diagnostic test | Breast cancer patients eligible to neoadjuvant systemic therapy |
Primary outcome
Describe miRNA 21 expression level before and after neoadjuvant systemic therapy in breast cancer patient.
Time frame: 1 year
miRNA 21 expression level before and after neoadjuvant systemic therapy
2 secondary outcomes
Measure relation between miRNA 21 expression level before and after neoadjuvant systemic therapy and pathological response.
Time frame: 1 year
Measure relation between the miRNA 21 expression and the clinicopathological parameters of Breast Cancer patients.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
- Results publication: PubMed 20082533Mei M, Ren Y, Zhou X, Yuan XB, Han L, Wang GX, Jia Z, Pu PY, Kang CS, Yao Z. Downregulation of miR-21 enhances chemotherapeutic effect of taxol in breast carcinoma cells. Technol Cancer Res Treat. 2010 Feb;9(1):77-86. doi: 10.1177/153303461000900109.
- Results publication: PubMed 27696295Yadav P, Mirza M, Nandi K, Jain SK, Kaza RC, Khurana N, Ray PC, Saxena A. Serum microRNA-21 expression as a prognostic and therapeutic biomarker for breast cancer patients. Tumour Biol. 2016 Nov;37(11):15275-15282. doi: 10.1007/s13277-016-5361-y. Epub 2016 Sep 30.
- Results publication: PubMed 24172333Ling H, Fabbri M, Calin GA. MicroRNAs and other non-coding RNAs as targets for anticancer drug development. Nat Rev Drug Discov. 2013 Nov;12(11):847-65. doi: 10.1038/nrd4140.
- Results publication: PubMed 16989803Zhang B, Pan X, Cobb GP, Anderson TA. microRNAs as oncogenes and tumor suppressors. Dev Biol. 2007 Feb 1;302(1):1-12. doi: 10.1016/j.ydbio.2006.08.028. Epub 2006 Aug 16.
- Results publication: PubMed 26891730Petrovic N. miR-21 Might be Involved in Breast Cancer Promotion and Invasion Rather than in Initial Events of Breast Cancer Development. Mol Diagn Ther. 2016 Apr;20(2):97-110. doi: 10.1007/s40291-016-0186-3.
- Results publication: PubMed 21219636Yan LX, Wu QN, Zhang Y, Li YY, Liao DZ, Hou JH, Fu J, Zeng MS, Yun JP, Wu QL, Zeng YX, Shao JY. Knockdown of miR-21 in human breast cancer cell lines inhibits proliferation, in vitro migration and in vivo tumor growth. Breast Cancer Res. 2011 Jan 10;13(1):R2. doi: 10.1186/bcr2803.
- Results publication: PubMed 24606718Chen L, Bourguignon LY. Hyaluronan-CD44 interaction promotes c-Jun signaling and miRNA21 expression leading to Bcl-2 expression and chemoresistance in breast cancer cells. Mol Cancer. 2014 Mar 8;13:52. doi: 10.1186/1476-4598-13-52.
- Results publication: PubMed 28683441Schwarzenbach H. Clinical Relevance of Circulating, Cell-Free and Exosomal microRNAs in Plasma and Serum of Breast Cancer Patients. Oncol Res Treat. 2017;40(7-8):423-429. doi: 10.1159/000478019. Epub 2017 Jun 28.
- Results publication: PubMed 30099860Zhu W, Liu M, Fan Y, Ma F, Xu N, Xu B. Dynamics of circulating microRNAs as a novel indicator of clinical response to neoadjuvant chemotherapy in breast cancer. Cancer Med. 2018 Sep;7(9):4420-4433. doi: 10.1002/cam4.1723. Epub 2018 Aug 11.
- Results publication: PubMed 22523546Wang H, Tan G, Dong L, Cheng L, Li K, Wang Z, Luo H. Circulating MiR-125b as a marker predicting chemoresistance in breast cancer. PLoS One. 2012;7(4):e34210. doi: 10.1371/journal.pone.0034210. Epub 2012 Apr 16.
- Results publication: PubMed 28412211Liu B, Su F, Chen M, Li Y, Qi X, Xiao J, Li X, Liu X, Liang W, Zhang Y, Zhang J. Serum miR-21 and miR-125b as markers predicting neoadjuvant chemotherapy response and prognosis in stage II/III breast cancer. Hum Pathol. 2017 Jun;64:44-52. doi: 10.1016/j.humpath.2017.03.016. Epub 2017 Apr 12.
- Individual participant dataSharing planned: No
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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.
Ebtehal M Salah principal investigator
Assistant lecturer of clinical oncology
Iman Sharawy study director
Professor of clinical oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Carcinoma, run by Ain Shams University at 1 site in Egypt.
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 6 inclusion and 6 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 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Ebtehal M Salah, MD (+201013678565, ebtehal.mohamed@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe miRNA 21 expression level before and after neoadjuvant systemic therapy in breast cancer patient. (time frame: 1 year). 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 NCT05151224, which also lists 11 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 9 Dec 2021.