miRNA and Relevant Biomarkers of BC Patients Undergoing Neoadjuvant Treatment

NCT ID: NCT03779022

Last Updated: 2019-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-01

Study Completion Date

2019-12-31

Brief Summary

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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

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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

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

microRNA

Intervention Type GENETIC

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.

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.

microRNA

Intervention Type GENETIC

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.

Interventions

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microRNA

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.

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

1. Early breast cancer patients;
2. Stage II-III disease;
3. sign informed consent form;
4. receive neoadjuvant treatment;
5. Age between 18-75.

Exclusion Criteria

1. Women during pregnancy;
2. Metastasis patients or stage IV breast cancer patients;
3. Male breast cancer patients;
4. Inflammatory breast cancer patients;
5. Patients with neoadjuvant endocrine treatment.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cui Yimin

OTHER

Sponsor Role lead

Responsible Party

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Cui Yimin

Director of pharmacy, M.D & Ph.D

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Yimin Cui, Ph.D & M.D

Role: STUDY_DIRECTOR

Peking University First Hospital

Locations

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Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qian Xiang, Ph.D

Role: CONTACT

86 10 66110802

Zhuo Zhang, M.Sc

Role: CONTACT

86 10 66110802

Facility Contacts

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Zhuo Zhang

Role: primary

1066110802

References

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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.

Reference Type BACKGROUND
PMID: 25137071 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22523546 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22156446 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30099860 (View on PubMed)

Other Identifiers

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miRNA-NAT-BC

Identifier Type: -

Identifier Source: org_study_id

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