<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/NCT03255265</url>
  </required_header>
  <id_info>
    <org_study_id>cf-DNA</org_study_id>
    <nct_id>NCT03255265</nct_id>
  </id_info>
  <brief_title>Clinical Study of Microchimerism and cfDNA as Biomarkers for Acute Rejection After Organ Transplantation</brief_title>
  <acronym>CSMCDTITAROT</acronym>
  <official_title>Microchimerism and cfDNA as Biomarkers for Acute Rejection After Organ Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fuzhou General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>309th Hospital of Chinese People's Liberation Army</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tianjin First Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>RenJi Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ruijin Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital, Sun Yat-Sen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Third Affiliated Hospital, Sun Yat-Sen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Huazhong University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>West China Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Central South University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Third Xiangya Hospital of Central South University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital Xi'an Jiaotong University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Qianfoshan Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Wuxi People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Second Affiliated Hospital of Guangzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fuzhou General Hospital</source>
  <brief_summary>
    <textblock>
      Organ transplantation has become an effective therapy for patients with end-stage organ&#xD;
      failure at present. Rejection is still the most common cause of early dysfunction after organ&#xD;
      transplantation. A large number of experimental and clinical data are suggesting that the&#xD;
      formation of microchimer can successfully achieve donor-specific immune tolerance after&#xD;
      transplantation. The formation of microchimerism may be one of the long-term survival&#xD;
      mechanisms of transplantation, and the detection of microchimerism after transplantation can&#xD;
      effectively predict the rejection of grafts. Scientists from Stanford University in the&#xD;
      United States continued to report in 2014 and 2015 that using a new generation of&#xD;
      high-throughput sequencing technology (NGS) to detect the level of free DNA from donor in&#xD;
      blood plasma of recipients after cardiac and lung transplantation. The investigators found&#xD;
      the level of free DNA in donor significantly increased when acute or chronic rejection&#xD;
      happens, thus it may be used as a reflection of rejection or graft injury markers.&#xD;
&#xD;
      It has been reported that microchimerization and donor free DNA levels are associated with&#xD;
      rejection after organ transplantation, but these studies are mostly based on a small number&#xD;
      of cases and the results of which re qualitative and can not provide a specific&#xD;
      microchimerization rate due to limited detection techniques. Therefore, in order to clarify&#xD;
      the role of microchimerism and the level of cell-free DNA in donor in organ transplantation&#xD;
      tolerance, it is necessary to use a new generation of detection technology for multi-center&#xD;
      study with large samples.&#xD;
&#xD;
      Clinical trial was used to evaluate the clinical prediction and diagnostic value of&#xD;
      microchimerization rate and donor cfDNA for acute rejection after organ transplantation.&#xD;
&#xD;
      950 cases of organ transplantation, of which 600 cases of renal transplantation, 300 cases of&#xD;
      liver transplantation and 50 cases of lung transplantation.8 ml peripheral blood was&#xD;
      collected in 1 tubes with EDTA anticoagulation. The timing of the collection was as follows:&#xD;
      Patients with routine treatment after transplantation were preformed once every one weeks for&#xD;
      one months and then every 3 month until the one year. In case of acute rejection, the&#xD;
      additional blood was collected once on the day of diagnosis, and once after the treatment&#xD;
      remission. All the samples were detected for microchimerism and cfDNA.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Organ transplantation has become an effective therapy for patients with end-stage organ&#xD;
      failure at present. Since the launch of pilot voluntary organ donation after death of&#xD;
      citizens in 2010, the voluntary organ donation has become the only legitimate source of organ&#xD;
      transplants in 2015, and the transition from relying on the judicial channels to obtain the&#xD;
      organs to voluntary donation of citizens has been successfully achieved in China, donation&#xD;
      cases and the number increased year by year. At present, the annual number of organ&#xD;
      transplantation in China has exceeded 10,000 cases, of which kidney transplantation and liver&#xD;
      transplantation were in the lead, respectively with more than 5000 cases and 2000 cases.&#xD;
&#xD;
      Rejection is still the most common cause of early dysfunction after organ transplantation,&#xD;
      and the mismatching of major histocompatibility antigens (MHC, human MHC, also known as HLA)&#xD;
      of the donor and recipient is the major cause of rejection after transplantation. Therefore,&#xD;
      the importance of matching in organ transplantation has been widely accepted. HLA typing and&#xD;
      HLA high resolution typing are becoming more and more common. At the same time, the latest&#xD;
      international research shows that low-resolution HLA typing in organ transplantation also can&#xD;
      cause significant rejection, while HLA high-resolution typing, the future trend, can improve&#xD;
      the overall survival rate. Furthermore, NGS high-throughput sequencing will push HLA&#xD;
      high-resolution classification to a new height.&#xD;
&#xD;
      Besides HLA matching, recipients can set up specific immune tolerance to donor grafts which&#xD;
      will significantly affect long-term survival after operation. A large number of experimental&#xD;
      and clinical data have suggested that the microchimerism formation can successfully&#xD;
      facilitate donor-specific immune tolerance after transplantation. Chimera refers to the&#xD;
      condition of the cells from the donor and from the recipient coexist and move to each other&#xD;
      as that the donor cells exist in the recipient body after receiving the allograft or&#xD;
      xenograft transplantation and the recipient cells exist in the graft as well. Among them,&#xD;
      microchimera refers to the low levels of donor cells (usually less than 0.01%) in the&#xD;
      peripheral blood circulation of transplant recipients, which is commonly seen in the patients&#xD;
      with solid organ transplantation. The concept of microchimerism was first proposed by Thomas&#xD;
      Starzl in the Medicine School of University of Pittsburgh in the 1990s, which pointed out&#xD;
      that between the microchimerism and transplant immune tolerance lie a possible cause and&#xD;
      effect relationship. The long-standing presence of microchimerism can lead to the recipient's&#xD;
      tolerance to the donor organ. The more passer-by cells the organ has, the more cells it&#xD;
      shifts out, making it easier to form transplantation tolerance, which explains the phenomenon&#xD;
      of the mildest rejection after liver transplantation.&#xD;
&#xD;
      Several methods have been found to induce microchimerism, including donor-specific&#xD;
      transfusion, donor bone marrow cell infusion, donor leukocyte infusion, spleen slice combined&#xD;
      with organ transplantation and so on.&#xD;
&#xD;
      The formation of microchimerism is probably one of the long-term survival mechanisms of the&#xD;
      transplanted graft, and the detection of microchimerism after transplantation can effectively&#xD;
      predict the immune tolerance and rejection of the graft, while there is no very effective&#xD;
      quantitation method.. In addition, the relationship between microchimerism and&#xD;
      immunotolerance remains questionable, such as to what level of the clinical microchimerism&#xD;
      formation that suggests stable immune tolerance, and whether it is possible to determine the&#xD;
      withdrawal of immunosuppressive agents by the detection of microchimerism and etc., these are&#xD;
      urgent problems remained to be solved and clarified. Based on the Insertion Deletion (InDel)&#xD;
      site combined with quantitative real-time polymerase chain reaction, the detection&#xD;
      sensitivity can reach 0.001% to 0.01%, which can accurately quantify the microchimerism level&#xD;
      and dynamically monitor microchimerism after the transplantation.&#xD;
&#xD;
      At the same time, scientists from Stanford University in the United States continued to&#xD;
      report in 2014 and 2015 that using a new generation of high-throughput sequencing technology&#xD;
      (NGS) to detect the level of donor derived cell free DNA(cf DNA) in blood plasma of&#xD;
      recipients after cardiac and lung transplantation. The investigators found that the level of&#xD;
      donor-derived cf DNA was significantly increased when acute or chronic rejection happens,&#xD;
      thus it could be used as a marker to reflect rejection or graft injury.&#xD;
&#xD;
      It has been reported that microchimerization and donor-cfDNA levels are correlated with&#xD;
      rejection after organ transplantation, but these studies are mostly based on a small number&#xD;
      of cases and the results of which are qualitative or with low resolution value due to limited&#xD;
      detection techniques thus can not provide a specific microchimerism rate.&#xD;
&#xD;
      Therefore, The investigators need to clarify the role of microchimerism and the level of&#xD;
      donor -derived cf DNA during graft injury as well as rejection after transplantation using a&#xD;
      new generation of detection technology for multi-center study with large sample size.&#xD;
&#xD;
      In this study, 950 cases of organ transplantation, of which 600 cases of renal&#xD;
      transplantation, 300 cases of liver transplantation and 50 cases of lung transplantation will&#xD;
      be recruited and detected. 8 ml peripheral blood will be collected in 1 tubes with EDTA&#xD;
      anticoagulation. The time points of the collection are as follows: Patients with routine&#xD;
      treatment after transplantation are preformed once a week for 1 month and then at 3, 6 and 12&#xD;
      months after transplantation. In case of acute rejection, the additional blood will be&#xD;
      collected once on the day of diagnosis, and once after 7 days treatment remission. All the&#xD;
      samples were detected for microchimerism and cfDNA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">September 28, 2021</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>Quantification of the donor microchimerism in recipients was conducted once a week for 1 month and then at 3, 6 and 12 months after transplantation.</measure>
    <time_frame>2017.4.1-2021.4.31</time_frame>
    <description>Around the 8mL peripheral whole blood was collected and the DNA in hemocytes was extracted for qPCR analysis. During which 30 target genomic genes were amplified, the donor microchimerism rate was quantified by former differentiating of InDel sites between the donor and the recipient.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quantification of the donor derived cfDNA rate in recipients was conducted once a week for 1 month and then at 3, 6 and 12 months after transplantation.</measure>
    <time_frame>2017.4.1-2021.4.31</time_frame>
    <description>Around the 8mL peripheral whole blood was collected and the plasma was separated for following next-generation-sequencing by Illumina system (USA). The genotyping of the donor and the recipient</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">950</enrollment>
  <condition>Organ Transplant Rejection</condition>
  <arm_group>
    <arm_group_label>Acute rejection</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>No acute rejection</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>no interventions</intervention_name>
    <description>no interventions</description>
    <arm_group_label>Acute rejection</arm_group_label>
    <arm_group_label>No acute rejection</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        aged above 18 years old single organ transplant patients (first or again); Guardian or&#xD;
        self-signed informed consent.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Single-organ transplant recipients aged above 18 years old Recipients of re-do organ&#xD;
             transplants&#xD;
&#xD;
          -  Recipients with no systemic acute or chronic infections, infectious diseases;&#xD;
&#xD;
          -  Recipients with no severe systemic diseases and/or spiritual system diseases&#xD;
&#xD;
          -  Recipients or families signed the consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Organ transplant recipients whose donor is child (under the age of 18 years old)&#xD;
&#xD;
          -  Patients wait-listed for multiple organ transplantation&#xD;
&#xD;
          -  Unable or unwilling to follow up regularly&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jian ming Tan, Chief Physician</last_name>
    <phone>86-13375918000</phone>
    <email>tanjm156@xmu.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jun Lu, Chief Physician</last_name>
    <phone>86-13599091436</phone>
    <email>junlu.heather@xmu.edu.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Fuzhou General Hospital, Xiamen Univ Fuzhou, Fujian China</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <zip>350025</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jian ming Tan</last_name>
      <phone>86-13375918000</phone>
      <email>tjming156@xmu.edu.cn</email>
    </contact>
    <contact_backup>
      <last_name>Jun Lun</last_name>
      <phone>86-13599091436</phone>
      <email>junlu.heather@xmu.edu.cn</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
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    <citation>Espinel CH, Mendez-Picon G, Currier C, Novello A, Helfrich GB, Lee HM. FE Na effective in early diagnosis of acute rejection after kidney transplantation. Proc Clin Dial Transplant Forum. 1979;9:256-9. No abstract available.</citation>
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    <citation>Garcia Moreira V, Prieto Garcia B, Baltar Martin JM, Ortega Suarez F, Alvarez FV. Cell-free DNA as a noninvasive acute rejection marker in renal transplantation. Clin Chem. 2009 Nov;55(11):1958-66. doi: 10.1373/clinchem.2009.129072. Epub 2009 Sep 3.</citation>
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    <citation>Germani G, Rodriguez-Castro K, Russo FP, Senzolo M, Zanetto A, Ferrarese A, Burra P. Markers of acute rejection and graft acceptance in liver transplantation. World J Gastroenterol. 2015 Jan 28;21(4):1061-8. doi: 10.3748/wjg.v21.i4.1061.</citation>
    <PMID>25632178</PMID>
  </reference>
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    <citation>Gielis EM, Ledeganck KJ, De Winter BY, Del Favero J, Bosmans JL, Claas FH, Abramowicz D, Eikmans M. Cell-Free DNA: An Upcoming Biomarker in Transplantation. Am J Transplant. 2015 Oct;15(10):2541-51. doi: 10.1111/ajt.13387. Epub 2015 Jul 16.</citation>
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    <citation>Gierej B, Kobryn K, Gierej P, Gornicka B. C4d in acute rejection after liver transplantation and its usefulness in differential diagnosis between acute liver rejection and hepatitis C recurrence. Ann Transplant. 2014 Aug 1;19:373-81. doi: 10.12659/AOT.890234.</citation>
    <PMID>25082343</PMID>
  </reference>
  <reference>
    <citation>Gozzo ML, Avolio AW, Colacicco L, Agnes S, Forni F, Barbaresi G, Castagneto M. Mitochondrial liver enzymes and the ratio between mitochondrial and cytoplasmic enzymes in the differential diagnosis of acute rejection after liver transplantation. Transplant Proc. 1993 Apr;25(2):1760-1. No abstract available.</citation>
    <PMID>8097065</PMID>
  </reference>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>February 13, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>August 16, 2017</last_update_submitted>
  <last_update_submitted_qc>August 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>organ transplantation</keyword>
  <keyword>cfDNA</keyword>
  <keyword>microchimerism</keyword>
  <keyword>acute rejection</keyword>
  <!-- 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/NCT03255265
org study id: cf-DNA
nct id: NCT03255265
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Organ transplantation has become an effective therapy for patients with end-stage organ
      failure at present. Rejection is still the most common cause of early dysfunction after organ
      transplantation. A large number of experimental and clinical data are suggesting that the
      formation of microchimer can successfully achieve donor-specific immune tolerance after
      transplantation. The formation of microchimerism may be one of the long-term survival
      mechanisms of transplantation, and the detection of microchimerism after transplantation can
      effectively predict the rejection of grafts. Scientists from Stanford University in the
      United States continued to report in 2014 and 2015 that using a new generation of
      high-throughput sequencing technology (NGS) to detect the level of free DNA from donor in
      blood plasma of recipients after cardiac and lung transplantation. The investigators found
      the level of free DNA in donor significantly increased when acute or chronic rejection
      happens, thus it may be used as a reflection of rejection or graft injury markers.

      It has been reported that microchimerization and donor free DNA levels are associated with
      rejection after organ transplantation, but these studies are mostly based on a small number
      of cases and the results of which re qualitative and can not provide a specific
      microchimerization rate due to limited detection techniques. Therefore, in order to clarify
      the role of microchimerism and the level of cell-free DNA in donor in organ transplantation
      tolerance, it is necessary to use a new generation of detection technology for multi-center
      study with large samples.

      Clinical trial was used to evaluate the clinical prediction and diagnostic value of
      microchimerization rate and donor cfDNA for acute rejection after organ transplantation.

      950 cases of organ transplantation, of which 600 cases of renal transplantation, 300 cases of
      liver transplantation and 50 cases of lung transplantation.8 ml peripheral blood was
      collected in 1 tubes with EDTA anticoagulation. The timing of the collection was as follows:
      Patients with routine treatment after transplantation were preformed once every one weeks for
      one months and then every 3 month until the one year. In case of acute rejection, the
      additional blood was collected once on the day of diagnosis, and once after the treatment
      remission. All the samples were detected for microchimerism and cfDNA.
Organ transplantation has become an effective therapy for patients with end-stage organ
      failure at present. Since the launch of pilot voluntary organ donation after death of
      citizens in 2010, the voluntary organ donation has become the only legitimate source of organ
      transplants in 2015, and the transition from relying on the judicial channels to obtain the
      organs to voluntary donation of citizens has been successfully achieved in China, donation
      cases and the number increased year by year. At present, the annual number of organ
      transplantation in China has exceeded 10,000 cases, of which kidney transplantation and liver
      transplantation were in the lead, respectively with more than 5000 cases and 2000 cases.

      Rejection is still the most common cause of early dysfunction after organ transplantation,
      and the mismatching of major histocompatibility antigens (MHC, human MHC, also known as HLA)
      of the donor and recipient is the major cause of rejection after transplantation. Therefore,
      the importance of matching in organ transplantation has been widely accepted. HLA typing and
      HLA high resolution typing are becoming more and more common. At the same time, the latest
      international research shows that low-resolution HLA typing in organ transplantation also can
      cause significant rejection, while HLA high-resolution typing, the future trend, can improve
      the overall survival rate. Furthermore, NGS high-throughput sequencing will push HLA
      high-resolution classification to a new height.

      Besides HLA matching, recipients can set up specific immune tolerance to donor grafts which
      will significantly affect long-term survival after operation. A large number of experimental
      and clinical data have suggested that the microchimerism formation can successfully
      facilitate donor-specific immune tolerance after transplantation. Chimera refers to the
      condition of the cells from the donor and from the recipient coexist and move to each other
      as that the donor cells exist in the recipient body after receiving the allograft or
      xenograft transplantation and the recipient cells exist in the graft as well. Among them,
      microchimera refers to the low levels of donor cells (usually less than 0.01%) in the
      peripheral blood circulation of transplant recipients, which is commonly seen in the patients
      with solid organ transplantation. The concept of microchimerism was first proposed by Thomas
      Starzl in the Medicine School of University of Pittsburgh in the 1990s, which pointed out
      that between the microchimerism and transplant immune tolerance lie a possible cause and
      effect relationship. The long-standing presence of microchimerism can lead to the recipient's
      tolerance to the donor organ. The more passer-by cells the organ has, the more cells it
      shifts out, making it easier to form transplantation tolerance, which explains the phenomenon
      of the mildest rejection after liver transplantation.

      Several methods have been found to induce microchimerism, including donor-specific
      transfusion, donor bone marrow cell infusion, donor leukocyte infusion, spleen slice combined
      with organ transplantation and so on.

      The formation of microchimerism is probably one of the long-term survival mechanisms of the
      transplanted graft, and the detection of microchimerism after transplantation can effectively
      predict the immune tolerance and rejection of the graft, while there is no very effective
      quantitation method.. In addition, the relationship between microchimerism and
      immunotolerance remains questionable, such as to what level of the clinical microchimerism
      formation that suggests stable immune tolerance, and whether it is possible to determine the
      withdrawal of immunosuppressive agents by the detection of microchimerism and etc., these are
      urgent problems remained to be solved and clarified. Based on the Insertion Deletion (InDel)
      site combined with quantitative real-time polymerase chain reaction, the detection
      sensitivity can reach 0.001% to 0.01%, which can accurately quantify the microchimerism level
      and dynamically monitor microchimerism after the transplantation.

      At the same time, scientists from Stanford University in the United States continued to
      report in 2014 and 2015 that using a new generation of high-throughput sequencing technology
      (NGS) to detect the level of donor derived cell free DNA(cf DNA) in blood plasma of
      recipients after cardiac and lung transplantation. The investigators found that the level of
      donor-derived cf DNA was significantly increased when acute or chronic rejection happens,
      thus it could be used as a marker to reflect rejection or graft injury.

      It has been reported that microchimerization and donor-cfDNA levels are correlated with
      rejection after organ transplantation, but these studies are mostly based on a small number
      of cases and the results of which are qualitative or with low resolution value due to limited
      detection techniques thus can not provide a specific microchimerism rate.

      Therefore, The investigators need to clarify the role of microchimerism and the level of
      donor -derived cf DNA during graft injury as well as rejection after transplantation using a
      new generation of detection technology for multi-center study with large sample size.

      In this study, 950 cases of organ transplantation, of which 600 cases of renal
      transplantation, 300 cases of liver transplantation and 50 cases of lung transplantation will
      be recruited and detected. 8 ml peripheral blood will be collected in 1 tubes with EDTA
      anticoagulation. The time points of the collection are as follows: Patients with routine
      treatment after transplantation are preformed once a week for 1 month and then at 3, 6 and 12
      months after transplantation. In case of acute rejection, the additional blood will be
      collected once on the day of diagnosis, and once after 7 days treatment remission. All the
      samples were detected for microchimerism and cfDNA.
observational model: Cohort
time perspective: Prospective
measure: Quantification of the donor microchimerism in recipients was conducted once a week for 1 month and then at 3, 6 and 12 months after transplantation.
time frame: 2017.4.1-2021.4.31
description: Around the 8mL peripheral whole blood was collected and the DNA in hemocytes was extracted for qPCR analysis. During which 30 target genomic genes were amplified, the donor microchimerism rate was quantified by former differentiating of InDel sites between the donor and the recipient.
measure: Quantification of the donor derived cfDNA rate in recipients was conducted once a week for 1 month and then at 3, 6 and 12 months after transplantation.
time frame: 2017.4.1-2021.4.31
description: Around the 8mL peripheral whole blood was collected and the plasma was separated for following next-generation-sequencing by Illumina system (USA). The genotyping of the donor and the recipient
arm group label: Acute rejection
arm group label: No acute rejection
intervention type: Other
intervention name: no interventions
description: no interventions
arm group label: Acute rejection
arm group label: No acute rejection
blood
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Jian ming Tan, Chief Physician
phone: 86-13375918000
email: tanjm156@xmu.edu.cn
last name: Jun Lu, Chief Physician
phone: 86-13599091436
email: junlu.heather@xmu.edu.cn
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
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responsible party type: Sponsor