Breast CancerNCT03779022
miRNA and Relevant Biomarkers of BC Patients Undergoing Neoadjuvant Treatment
An observational study of Breast Cancer, run by Cui Yimin at 1 site in China.
Trial summary
MicroRNA (miRNA) is a type of endogenous non-coding RNA. They are responsible for post-transcriptional regulation and participate in many vital biological processes. Expression profiling has shown that miRNAs can distinguish between normal breast and tumor tissues. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- microRNA
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2015to 31 Dec 2019
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female, Breast Cancer, >18 years,<75 years, early stage breast cancer patients, with Stage II-III disease
Who may be able to join
- Early breast cancer patients;
- Stage II-III disease;
- sign informed consent form;
- receive neoadjuvant treatment;
- Age between 18-75.
Who cannot join
- Women during pregnancy;
- Metastasis patients or stage IV breast cancer patients;
- Male breast cancer patients;
- Inflammatory breast cancer patients;
- Patients with neoadjuvant endocrine treatment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Zhuo Zhang, 1066110802, zhangz1023@163.com
About this study
Official title: MicroRNA and Relevant Biomarkers of Breast Cancer in Patients Undergoing Neoadjuvant Treatment
MicroRNA (miRNA) is a type of endogenous non-coding RNA. They are responsible for post-transcriptional regulation and participate in many vital biological processes. Expression profiling has shown that miRNAs can distinguish between normal breast and tumor tissues. In recent years, circulating miRNAs have become promising biomarkers based on their stability and their non-invasive testing and feasibility in clinical practices.
Read the detailed description
Current reports showed that serum microRNA expression could be used as an early marker for determining the breast cancer risk. The concentrations of some circulating microRNAs in human breast cancer have been correlated with tumor development and progression. Aberrant miRNA expression may be involved in drug resistance to various chemotherapeutic agents in breast cancer. Therefore, we hope to investigate the value of miRNAs in predicting the effect in breast cancer neoadjuvant treatment.
- Conditions
- Breast Cancer
- Being tested
- microRNA
- Keywords
- breast cancer, biomarker, neoadjuvant treatment, microRNA, response
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microRNAGenetic
The level of microRNA in plasma will be detected by TaqMan in screening phase and by quantitative Real-time PCR (qRT-PCR) in validation phase.
| Study group | Role | What they receive |
|---|---|---|
| Sensitive | Sensitive group was defined ad complete response (CR) and/or partial response (PR). Blood samples for microRNA were collected before neoadjuvant chemotherapy, evaluation of clinical disease response and surgery. Receives: Genetic: microRNA | |
| Resistant | Resistant group was defined ad progression disease (PD) and/or stable disease (SD). Blood samples for microRNA were collected before neoadjuvant chemotherapy, evaluation of clinical disease response and surgery. Receives: Genetic: microRNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response
Clinical disease response was evaluated for every two cycles of chemotherapy till surgery with RECIST criteria (RECIST 1.1). Resistant group was defined ad progression disease (PD) and/or stable disease (SD).Evaluation in breast lesions by MRI or mammography. The same imaging methods were used throughout treatment for a given patient. Blood samples for microRNA were collected before neoadjuvant chemotherapy, evaluation of clinical disease response and surgery.
Clinical disease response was evaluated for every two cycles of chemotherapy till surgery with RECIST criteria (RECIST 1.1). Evaluation in breast lesions by MRI or mammography. The same imaging methods were used throughout treatment for a given patient.
Measured: Every 2 cycles, up to surgery (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start1 Nov 2015
- Primary completion30 Sep 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cui Yimin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cui Yimin, Peking University First Hospital
- Investigators
- Yimin Cui, Ph.D & M.D, Study director, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03779022
- Sponsor's protocol ID
- miRNA-NAT-BC
- Status last verified
- Aug 2019
- First submitted
- 12 Dec 2018
- Last updated
- 28 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We would not like to share individual participant data (IPD) but share the result after statistical analysis. If IPD was needed, please contact us by e-mail.
Publications
Li Q, Liu M, Ma F, Luo Y, Cai R, Wang L, Xu N, Xu B. Circulating miR-19a and miR-205 in serum may predict the sensitivity of luminal A subtype of breast cancer patients to neoadjuvant chemotherapy with epirubicin plus paclitaxel. PLoS One. 2014 Aug 19;9(8):e104870. doi: 10.1371/journal.pone.0104870. eCollection 2014.
PubMed 25137071Wang 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 22523546Zhao R, Wu J, Jia W, Gong C, Yu F, Ren Z, Chen K, He J, Su F. Plasma miR-221 as a predictive biomarker for chemoresistance in breast cancer patients who previously received neoadjuvant chemotherapy. Onkologie. 2011;34(12):675-80. doi: 10.1159/000334552. Epub 2011 Nov 23.
PubMed 22156446Zhu 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 30099860
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MicroRNA and Relevant Biomarkers of Breast Cancer in Patients Undergoing Neoadjuvant Treatment
- ClinicalTrials.gov ID
- NCT03779022
- Acronym / sponsor ID
- miRNA-NAT-BC
- Conditions
- Breast Cancer
- Keywords
- breast cancer, biomarker, neoadjuvant treatment, microRNA, response
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cui YiminUniversity, hospital or other
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 19 Dec 2018 (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.
MicroRNA (miRNA) is a type of endogenous non-coding RNA. They are responsible for post-transcriptional regulation and participate in many vital biological processes. Expression profiling has shown that miRNAs can distinguish between normal breast and tumor tissues. In recent years, circulating miRNAs have become promising biomarkers based on their stability and their non-invasive testing and feasibility in clinical practices.
Detailed description
Current reports showed that serum microRNA expression could be used as an early marker for determining the breast cancer risk. The concentrations of some circulating microRNAs in human breast cancer have been correlated with tumor development and progression. Aberrant miRNA expression may be involved in drug resistance to various chemotherapeutic agents in breast cancer. Therefore, we hope to investigate the value of miRNAs in predicting the effect in breast cancer neoadjuvant treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sensitive | – | Genetic: microRNASensitive group was defined ad complete response (CR) and/or partial response (PR). Blood samples for microRNA were collected before neoadjuvant chemotherapy, evaluation of clinical disease response and surgery. |
| Resistant | – | Genetic: microRNAResistant group was defined ad progression disease (PD) and/or stable disease (SD). Blood samples for microRNA were collected before neoadjuvant chemotherapy, evaluation of clinical disease response and surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female, Breast Cancer, >18 years,<75 years, early stage breast cancer patients, with Stage II-III disease
Key inclusion criteria (5 listed)
- Early breast cancer patients;
- Stage II-III disease;
- sign informed consent form;
- receive neoadjuvant treatment;
- Age between 18-75.
Key exclusion criteria (5 listed)
- Women during pregnancy;
- Metastasis patients or stage IV breast cancer patients;
- Male breast cancer patients;
- Inflammatory breast cancer patients;
- Patients with neoadjuvant endocrine treatment.
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 |
|---|---|---|
| microRNAThe level of microRNA in plasma will be detected by TaqMan in screening phase and by quantitative Real-time PCR (qRT-PCR) in validation phase. | Genetic | Resistant, Sensitive |
Primary outcome
Objective Response
Time frame: Every 2 cycles, up to surgery (each cycle is 21 days)
Clinical disease response was evaluated for every two cycles of chemotherapy till surgery with RECIST criteria (RECIST 1.1). Resistant group was defined ad progression disease (PD) and/or stable disease (SD).Evaluation in breast lesions by MRI or mammography. The same imaging methods were used throughout treatment for a given patient. Blood samples for microRNA were collected before neoadjuvant chemotherapy, evaluation of clinical disease response and surgery. Clinical disease response was evaluated for every two cycles of chemotherapy till surgery with RECIST criteria (RECIST 1.1). Evaluation in breast lesions by MRI or mammography. The same imaging methods were used throughout treatment for a given patient.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Background: PubMed 25137071Li Q, Liu M, Ma F, Luo Y, Cai R, Wang L, Xu N, Xu B. Circulating miR-19a and miR-205 in serum may predict the sensitivity of luminal A subtype of breast cancer patients to neoadjuvant chemotherapy with epirubicin plus paclitaxel. PLoS One. 2014 Aug 19;9(8):e104870. doi: 10.1371/journal.pone.0104870. eCollection 2014.
- Background: 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.
- Background: PubMed 22156446Zhao R, Wu J, Jia W, Gong C, Yu F, Ren Z, Chen K, He J, Su F. Plasma miR-221 as a predictive biomarker for chemoresistance in breast cancer patients who previously received neoadjuvant chemotherapy. Onkologie. 2011;34(12):675-80. doi: 10.1159/000334552. Epub 2011 Nov 23.
- Background: 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.
- Individual participant dataSharing planned: No. We would not like to share individual participant data (IPD) but share the result after statistical analysis. If IPD was needed, please contact us by e-mail.
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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.
Yimin Cui, Ph.D & M.D study director
Peking University First Hospital
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 Cancer, run by Cui Yimin at 1 site in China.
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 5 inclusion and 5 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 28 Aug 2019. 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 China. 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 Qian Xiang, Ph.D (86 10 66110802, xiangqz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response (time frame: Every 2 cycles, up to surgery (each cycle is 21 days)). 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 NCT03779022, which also lists 4 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 28 Aug 2019; AzTrials last refreshed its copy on 8 Nov 2026.