<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03779022</url>
  </required_header>
  <id_info>
    <org_study_id>miRNA-NAT-BC</org_study_id>
    <nct_id>NCT03779022</nct_id>
  </id_info>
  <brief_title>miRNA and Relevant Biomarkers of BC Patients Undergoing Neoadjuvant Treatment</brief_title>
  <official_title>MicroRNA and Relevant Biomarkers of Breast Cancer in Patients Undergoing Neoadjuvant Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cui Yimin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University First Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      MicroRNA (miRNA) is a type of endogenous non-coding RNA. They are responsible for&#xD;
      post-transcriptional regulation and participate in many vital biological processes.&#xD;
      Expression profiling has shown that miRNAs can distinguish between normal breast and tumor&#xD;
      tissues. In recent years, circulating miRNAs have become promising biomarkers based on their&#xD;
      stability and their non-invasive testing and feasibility in clinical practices.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Current reports showed that serum microRNA expression could be used as an early marker for&#xD;
      determining the breast cancer risk. The concentrations of some circulating microRNAs in human&#xD;
      breast cancer have been correlated with tumor development and progression. Aberrant miRNA&#xD;
      expression may be involved in drug resistance to various chemotherapeutic agents in breast&#xD;
      cancer. Therefore, we hope to investigate the value of miRNAs in predicting the effect in&#xD;
      breast cancer neoadjuvant treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 1, 2015</start_date>
  <completion_date type="Anticipated">December 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Objective Response</measure>
    <time_frame>Every 2 cycles, up to surgery (each cycle is 21 days)</time_frame>
    <description>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.&#xD;
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.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Sensitive</arm_group_label>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Resistant</arm_group_label>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Genetic</intervention_type>
    <intervention_name>microRNA</intervention_name>
    <description>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.</description>
    <arm_group_label>Resistant</arm_group_label>
    <arm_group_label>Sensitive</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      For each patient, 4 mL of peripheral blood will be collected as per predesigned schedule.&#xD;
      Within 4 hours of blood drawl, samples will be centrifuged at 1500g for 10min at 4℃ to&#xD;
      separate the plasma supernatant. The plasma and the blood cell will be aliquoted and stored&#xD;
      at -80℃ until analysis, respectively.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Female, Breast Cancer, &gt;18 years,&lt;75 years, early stage breast cancer patients, with Stage&#xD;
        II-III disease&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Early breast cancer patients;&#xD;
&#xD;
          2. Stage II-III disease;&#xD;
&#xD;
          3. sign informed consent form;&#xD;
&#xD;
          4. receive neoadjuvant treatment;&#xD;
&#xD;
          5. Age between 18-75.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Women during pregnancy;&#xD;
&#xD;
          2. Metastasis patients or stage IV breast cancer patients;&#xD;
&#xD;
          3. Male breast cancer patients;&#xD;
&#xD;
          4. Inflammatory breast cancer patients;&#xD;
&#xD;
          5. Patients with neoadjuvant endocrine treatment.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female patients was eligible.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yimin Cui, Ph.D &amp; M.D</last_name>
    <role>Study Director</role>
    <affiliation>Peking University First Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Qian Xiang, Ph.D</last_name>
    <phone>86 10 66110802</phone>
    <email>xiangqz@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Zhuo Zhang, M.Sc</last_name>
    <phone>86 10 66110802</phone>
    <email>zhangz1023@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Peking University First Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100034</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhuo Zhang</last_name>
      <phone>1066110802</phone>
      <email>zhangz1023@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>25137071</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>22523546</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>22156446</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>30099860</PMID>
  </reference>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 16, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>August 27, 2019</last_update_submitted>
  <last_update_submitted_qc>August 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Peking University First Hospital</investigator_affiliation>
    <investigator_full_name>Cui Yimin</investigator_full_name>
    <investigator_title>Director of pharmacy, M.D &amp; Ph.D</investigator_title>
  </responsible_party>
  <keyword>breast cancer</keyword>
  <keyword>biomarker</keyword>
  <keyword>neoadjuvant treatment</keyword>
  <keyword>microRNA</keyword>
  <keyword>response</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_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.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03779022
org study id: miRNA-NAT-BC
nct id: NCT03779022
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Objective Response
time frame: Every 2 cycles, up to surgery (each cycle is 21 days)
description: 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.
arm group label: Sensitive
description: 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.
arm group label: Resistant
description: 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.
intervention type: Genetic
intervention name: microRNA
description: 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.
arm group label: Resistant
arm group label: Sensitive
For each patient, 4 mL of peripheral blood will be collected as per predesigned schedule.
      Within 4 hours of blood drawl, samples will be centrifuged at 1500g for 10min at 4℃ to
      separate the plasma supernatant. The plasma and the blood cell will be aliquoted and stored
      at -80℃ until analysis, respectively.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Female patients was eligible.
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Yimin Cui, Ph.D & M.D
role: Study Director
affiliation: Peking University First Hospital
last name: Qian Xiang, Ph.D
phone: 86 10 66110802
email: xiangqz@163.com
last name: Zhuo Zhang, M.Sc
phone: 86 10 66110802
email: zhangz1023@163.com
facility: 
status: Recruiting
contact: 
country: China
citation: 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.
PMID: 25137071
citation: 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.
PMID: 22523546
citation: 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.
PMID: 22156446
citation: 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.
PMID: 30099860
responsible party type: Sponsor-Investigator
investigator affiliation: Peking University First Hospital
investigator full name: Cui Yimin
investigator title: Director of pharmacy, M.D & Ph.D
mesh term: Breast Neoplasms
sharing ipd: No
ipd 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.