miRNA and Relevant Biomarkers of BC Patients Undergoing Neoadjuvant Treatment
August 27, 2019 updated by: Cui Yimin
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.
Study Overview
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 Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing
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Beijing, Beijing, China, 100034
- Recruiting
- Peking University First Hospital
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Contact:
- Zhuo Zhang
- Phone Number: 1066110802
- Email: zhangz1023@163.com
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Female, Breast Cancer, >18 years,<75 years, early stage breast cancer patients, with Stage II-III disease
Description
Inclusion Criteria:
- Early breast cancer patients;
- Stage II-III disease;
- sign informed consent form;
- receive neoadjuvant treatment;
- Age between 18-75.
Exclusion Criteria:
- Women during pregnancy;
- Metastasis patients or stage IV breast cancer patients;
- Male breast cancer patients;
- Inflammatory breast cancer patients;
- Patients with neoadjuvant endocrine treatment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
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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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
Every 2 cycles, up to surgery (each cycle is 21 days)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Yimin Cui, Ph.D & M.D, Peking University First Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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. Erratum In: PLoS One. 2015;10(8):e0136826.
- Wang 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.
- Zhao 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.
- Zhu 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2015
Primary Completion (Anticipated)
September 30, 2019
Study Completion (Anticipated)
December 31, 2019
Study Registration Dates
First Submitted
December 12, 2018
First Submitted That Met QC Criteria
December 16, 2018
First Posted (Actual)
December 19, 2018
Study Record Updates
Last Update Posted (Actual)
August 28, 2019
Last Update Submitted That Met QC Criteria
August 27, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- miRNA-NAT-BC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.