<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/NCT04434833</url>
  </required_header>
  <id_info>
    <org_study_id>NHL-scRNA</org_study_id>
    <nct_id>NCT04434833</nct_id>
  </id_info>
  <brief_title>A Single-cell Transcriptome Study in Patients With Non-Hodgkin's Lymphoma</brief_title>
  <official_title>A Single-cell Transcriptome Study in Patients With Non-Hodgkin's Lymphoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ruijin Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ruijin Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Using single-cell RNA sequencing, this study will explore the heterogeneity of lymphoma&#xD;
      inside and outside the lymph node, identify tumor specific molecular markers and cell&#xD;
      subgroups, explore the differences in tumor microenvironment composition, and provide a basis&#xD;
      for diagnosis and precision treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In recent decades, the incidence of lymphoma has been increasing year by year in the world.&#xD;
      Non-Hodgkin lymphoma accounts for about 90% of lymphoma, of which the classification is&#xD;
      complex and the efficacy is poor compared to Hodgkin's lymphoma. Non-Hodgkin's lymphoma is&#xD;
      often associated with the extra nodal involvement, and according to literature, extra nodal&#xD;
      lymphoma accounts for 1/3 to 1/2 of all non-Hodgkin lymphomas. Compared with non-Hodgkin's&#xD;
      lymphoma without extra nodal involvement, the prognosis of lymphoma with extra nodal&#xD;
      involvement was relatively poor. The recurrence rate was higher, and its incidence, histology&#xD;
      type, clinical staging and so on all had their own characteristics.&#xD;
&#xD;
      Tumor cells depend to some extent on the interaction with non-tumor cells and matrix&#xD;
      components of the tumor microenvironment to maintain survival and proliferation. In addition,&#xD;
      the non tumor cells and matrix components can mediate immunosuppressive action to promote&#xD;
      tumor escape from immunosurveillance, resulting in disease progression. At the same time,&#xD;
      more and more data show that the tumor microenvironment plays a key role in the development&#xD;
      of tumor resistance. The cellular composition and spatial properties of the tumor&#xD;
      microenvironment show significant heterogeneity, depending on a number of factors, including&#xD;
      subtypes of lymphomas and extra nodal sites of lymphomas. Studying the tumor microenvironment&#xD;
      will provide rationale for more precise target therapy. Through single-cell RNA sequencing,&#xD;
      this study hopes to identify the heterogeneity of nodal and extra nodal lymphoma cells, to&#xD;
      understand the differences in tumor microenvironment, and to provide a basis for diagnosis&#xD;
      and precision treatment.&#xD;
&#xD;
      There are new target drugs for different antigen targets. But patients may not be sensitive&#xD;
      to a certain drug, and the drug is often expensive, resulting in increased financial burden&#xD;
      on patients without efficacy. Therefore, the research for biomarkers to predict patient&#xD;
      efficacy and prognosis is particularly important.&#xD;
&#xD;
      The treatment efficacy of patients with relapsed lymphoma is often not good, so the&#xD;
      prediction and treatment of patients with high-risk of relapsing is a clinical significant&#xD;
      problem. On the basis of single-cell transcriptomics, this study hopes to find biomarkers for&#xD;
      predicting the relapse of lymphoma and provide new ideas for clinical diagnosis and&#xD;
      treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">June 2023</completion_date>
  <primary_completion_date type="Anticipated">June 2022</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>Extra nodal involvement</measure>
    <time_frame>At enrollment</time_frame>
    <description>Clinical diagnosis of lymphoma invasion in extra nodal organs with or without pathological confirmation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Complete response rate</measure>
    <time_frame>After 6 cycles of treatment (each cycle 21 to 28 days)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall response rate</measure>
    <time_frame>After 6 cycles of treatment (each cycle 21 to 28 days)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Relapse</measure>
    <time_frame>From the achievement of complete response to study completion, an average of 2 years</time_frame>
    <description>Clinical diagnosis of emergence of new lymphoma lesion with or without pathology confirmation</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Non Hodgkin Lymphoma</condition>
  <arm_group>
    <arm_group_label>Extra nodal diseases</arm_group_label>
    <description>Patients with both lymph node and extra nodal involvement.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Target drugs</arm_group_label>
    <description>Patients enrolled in clinical trials of novel target drugs.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Relapse</arm_group_label>
    <description>Patients with high risk of relapse.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The tissue puncture specimens patients with both lymph node and extra nodal involvement, or&#xD;
        patients at high risk of relapse, or patients receiving a novel target drug treatment will&#xD;
        be obtained and restored for single-cell RNA sequencing.&#xD;
&#xD;
        The clinical significance of single-cell RNA sequencing results will be explained combined&#xD;
        with the clinical data provided by Ruijin Hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with pathological confirmed diagnosis of non-Hodgkin's lymphomas.&#xD;
&#xD;
          -  Patients with both lymph node and extra nodal involvement, or patients at high risk of&#xD;
             relapse, or patients receiving a novel target drug treatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Weili Zhao, M.D. and PhD</last_name>
    <phone>13512112076</phone>
    <email>zhao.weili@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Shanghai Ruijin Hospital</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Weili Zhao, M.D. and Ph.D</last_name>
      <phone>13512112076</phone>
      <email>zhao.weili@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>July 6, 2020</last_update_submitted>
  <last_update_submitted_qc>July 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ruijin Hospital</investigator_affiliation>
    <investigator_full_name>Zhao Weili</investigator_full_name>
    <investigator_title>First Deputy Director of Shanghai Institute of Hematology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, Non-Hodgkin</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT04434833
org study id: NHL-scRNA
nct id: NCT04434833
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Using single-cell RNA sequencing, this study will explore the heterogeneity of lymphoma
      inside and outside the lymph node, identify tumor specific molecular markers and cell
      subgroups, explore the differences in tumor microenvironment composition, and provide a basis
      for diagnosis and precision treatment.
In recent decades, the incidence of lymphoma has been increasing year by year in the world.
      Non-Hodgkin lymphoma accounts for about 90% of lymphoma, of which the classification is
      complex and the efficacy is poor compared to Hodgkin's lymphoma. Non-Hodgkin's lymphoma is
      often associated with the extra nodal involvement, and according to literature, extra nodal
      lymphoma accounts for 1/3 to 1/2 of all non-Hodgkin lymphomas. Compared with non-Hodgkin's
      lymphoma without extra nodal involvement, the prognosis of lymphoma with extra nodal
      involvement was relatively poor. The recurrence rate was higher, and its incidence, histology
      type, clinical staging and so on all had their own characteristics.

      Tumor cells depend to some extent on the interaction with non-tumor cells and matrix
      components of the tumor microenvironment to maintain survival and proliferation. In addition,
      the non tumor cells and matrix components can mediate immunosuppressive action to promote
      tumor escape from immunosurveillance, resulting in disease progression. At the same time,
      more and more data show that the tumor microenvironment plays a key role in the development
      of tumor resistance. The cellular composition and spatial properties of the tumor
      microenvironment show significant heterogeneity, depending on a number of factors, including
      subtypes of lymphomas and extra nodal sites of lymphomas. Studying the tumor microenvironment
      will provide rationale for more precise target therapy. Through single-cell RNA sequencing,
      this study hopes to identify the heterogeneity of nodal and extra nodal lymphoma cells, to
      understand the differences in tumor microenvironment, and to provide a basis for diagnosis
      and precision treatment.

      There are new target drugs for different antigen targets. But patients may not be sensitive
      to a certain drug, and the drug is often expensive, resulting in increased financial burden
      on patients without efficacy. Therefore, the research for biomarkers to predict patient
      efficacy and prognosis is particularly important.

      The treatment efficacy of patients with relapsed lymphoma is often not good, so the
      prediction and treatment of patients with high-risk of relapsing is a clinical significant
      problem. On the basis of single-cell transcriptomics, this study hopes to find biomarkers for
      predicting the relapse of lymphoma and provide new ideas for clinical diagnosis and
      treatment.
observational model: Cohort
time perspective: Prospective
measure: Extra nodal involvement
time frame: At enrollment
description: Clinical diagnosis of lymphoma invasion in extra nodal organs with or without pathological confirmation
measure: Complete response rate
time frame: After 6 cycles of treatment (each cycle 21 to 28 days)
measure: Overall response rate
time frame: After 6 cycles of treatment (each cycle 21 to 28 days)
measure: Relapse
time frame: From the achievement of complete response to study completion, an average of 2 years
description: Clinical diagnosis of emergence of new lymphoma lesion with or without pathology confirmation
arm group label: Extra nodal diseases
description: Patients with both lymph node and extra nodal involvement.
arm group label: Target drugs
description: Patients enrolled in clinical trials of novel target drugs.
arm group label: Relapse
description: Patients with high risk of relapse.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 14 Years
maximum age: N/A
last name: Weili Zhao, M.D. and PhD
phone: 13512112076
email: zhao.weili@yahoo.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Ruijin Hospital
investigator full name: Zhao Weili
investigator title: First Deputy Director of Shanghai Institute of Hematology
mesh term: Lymphoma
mesh term: Lymphoma, Non-Hodgkin
sharing ipd: Undecided