<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/NCT01689350</url>
  </required_header>
  <id_info>
    <org_study_id>2012ZX09506001-004</org_study_id>
    <nct_id>NCT01689350</nct_id>
  </id_info>
  <brief_title>A Prospective Study of Cyclophosphamide in Systemic Lupus Erythematosus Treatment</brief_title>
  <acronym>SLE</acronym>
  <official_title>Prospective Study Based on Genetic Polymorphisms Related to Individual Variations of Side Effects of Cyclophosphamide in Systemic Lupus Erythematosus Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sun Yat-sen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>First Affiliated Hospital, Sun Yat-Sen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sun Yat-sen University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the genotype-based personal prescription of&#xD;
      cyclophosphamide with the traditional prescription.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cyclophosphamide (CPA) has been one of the most successful therapies for severe Systemic&#xD;
      lupus erythematosus (SLE). However, cyclophosphamide can cause severe side effects, including&#xD;
      bone marrow suppression, infection, gastrointestinal reaction, hemorrhagic cystitis, and the&#xD;
      etc. Significant variation in efficacy and toxicity of CPA has been observed. Since the&#xD;
      development of applicable therapeutic drug monitoring (TDM) of cyclophosphamide has been&#xD;
      reported, it will help to improve the efficacy and reduce toxicities in SLE treatment.&#xD;
      However, the TDM is a passive strategy which usually lags behind the appearance of&#xD;
      toxicities. Therefore，it is especially crucial to give individuals genotype-based personal&#xD;
      prescription of cyclophosphamide in order to gain the most effective therapies. Thus, the&#xD;
      purpose of this study is to compare the genotype-based personal prescription of&#xD;
      cyclophosphamide with the traditional prescription, in order to verify the efficacy of the&#xD;
      genotype-based personal prescription.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse Reaction (Leucopenia)</measure>
    <time_frame>one month</time_frame>
    <description>The count of white cells &lt; 4.0 × 10ˆ9/L in SLE patient who received CPA medication was considered as CPA-induced leucopenia.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse Reaction ( Infection )</measure>
    <time_frame>one month</time_frame>
    <description>Flu-like symptoms, Upper respiratory tract infection，and the etc.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">92</enrollment>
  <condition>Systemic Lupus Erythematosus</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The cases in control group received traditional therapy that the initial dose of cyclophosphamide (CPA) was 0.2-0.6g/week injection according to clinical experience.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Genetic: Genotype Detection To Genotype cases in the experimental group and divide them into three groups, including extensive metaboliser (EM), intermediate metaboliser (IM) and poor metaboliser (PM),with initial dose of CPA as 0.2g, 0.4g and 0.6g per week by injection, respectively.</description>
  </arm_group>
  <intervention>
    <intervention_type>Genetic</intervention_type>
    <intervention_name>Genotype Detection</intervention_name>
    <description>To Genotype cases in the experimental group and divide them into three groups, including extensive metaboliser (EM), intermediate metaboliser (IM) and poor metaboliser (PM).</description>
    <arm_group_label>Experimental Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The American College of Rheumatology established eleven criteria in 1982,which were&#xD;
             revised in 1997 as a classificatory instrument to operationalise the definition of SLE&#xD;
             in clinical trials.&#xD;
&#xD;
               1. Malar rash (rash on cheeks).&#xD;
&#xD;
               2. Discoid rash (red, scaly patches on skin that cause scarring).&#xD;
&#xD;
               3. Serositis: Pleurisy (inflammation of the membrane around the lungs) or&#xD;
                  pericarditis (inflammation of the membrane around the heart).&#xD;
&#xD;
               4. Oral ulcers (includes oral or nasopharyngeal ulcers).&#xD;
&#xD;
               5. Arthritis: nonerosive arthritis of two or more peripheral joints, with&#xD;
                  tenderness, swelling, or effusion.&#xD;
&#xD;
               6. Photosensitivity (exposure to ultraviolet light causes rash, or other symptoms of&#xD;
                  SLE flareups).&#xD;
&#xD;
               7. Blood-hematologic disorder-hemolytic anemia (low red blood cell count) or&#xD;
                  leukopenia (white blood cell count&lt;4000/µl), lymphopenia (&lt;1500/µl) or&#xD;
                  thrombocytopenia (&lt;100000/µl) in the absence of offending drug.&#xD;
                  Hypocomplementemia is also seen, due to either consumption of C3 and C4 by immune&#xD;
                  complex-induced inflammation or to congenitally complement deficiency, which may&#xD;
                  predispose to SLE.&#xD;
&#xD;
               8. Renal disorder: More than 0.5 g per day protein in urine or cellular casts seen&#xD;
                  in urine under a microscope.&#xD;
&#xD;
               9. Antinuclear antibody test positive.&#xD;
&#xD;
              10. Immunologic disorder: Positive anti-Smith, anti-ds DNA, antiphospholipid&#xD;
                  antibody, and/or false positive serological test for syphilis. Presence of&#xD;
                  anti-ss DNA in 70% of cases (though also positive with rheumatic disease and&#xD;
                  healthy persons).&#xD;
&#xD;
              11. Neurologic disorder: Seizures or psychosis. For the purpose of identifying&#xD;
                  patients for clinical studies, a person has SLE if any 4 out of 11 symptoms are&#xD;
                  present simultaneously or serially on two separate occasions. In the meantime,&#xD;
                  the case has one of the following conditions or more;&#xD;
&#xD;
               1. HIV (-);&#xD;
&#xD;
               2. Signed the informed consent;&#xD;
&#xD;
               3. Taking contraceptive measures during treatment period.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Poor compliance;&#xD;
&#xD;
          -  With lupus mental damage complication, occurrence of epilepsy or unable to express&#xD;
             subjective symptoms during the observation period.&#xD;
&#xD;
          -  Taking drugs that affect cytochrome P450 2B6, cytochrome P450 3A4 and cytochrome P450&#xD;
             2C19, except corticosteroids.&#xD;
&#xD;
          -  Abnormal liver function.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Huang Min, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Sun Yat-sen University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>School of Pharmaceutical Sciences Sun Yat-sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>September 17, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <results_first_submitted>June 10, 2014</results_first_submitted>
  <results_first_submitted_qc>August 27, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">September 8, 2014</results_first_posted>
  <last_update_submitted>August 27, 2014</last_update_submitted>
  <last_update_submitted_qc>August 27, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 8, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sun Yat-sen University</investigator_affiliation>
    <investigator_full_name>Lingyan Chen</investigator_full_name>
    <investigator_title>Master Graduate Student</investigator_title>
  </responsible_party>
  <keyword>Cyclophosphamide</keyword>
  <keyword>genotype-based therapy</keyword>
  <keyword>prospective study</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lupus Erythematosus, Systemic</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Experimental Group</title>
          <description>Cyclophosphamide (CPA) medication was according to the genotypes of SLE patients.</description>
        </group>
        <group group_id="P2">
          <title>Control Group</title>
          <description>Cyclophosphamide (CPA) medication was according to the traditional experiences.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="47"/>
                <participants group_id="P2" count="45"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="47"/>
                <participants group_id="P2" count="45"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>SLE patients who met the ACR criteria and applied CPA medication were included.</population>
      <group_list>
        <group group_id="B1">
          <title>Control Group</title>
          <description>45 cases in control group received traditional therapy that the initial dose of cyclophosphamide (CPA) was 0.2-0.6g/week injection according to clinical experience.</description>
        </group>
        <group group_id="B2">
          <title>Experimental Group</title>
          <description>47 cases in experimental group were genotyped as extensive metaboliser (EM), intermediate metaboliser (IM) and poor metaboliser (PM）with initial dose of CPA as 0.2g, 0.4g and 0.6g per week by injection, respectively.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="45"/>
            <count group_id="B2" value="47"/>
            <count group_id="B3" value="92"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30.40" spread="13.28"/>
                    <measurement group_id="B2" value="31.15" spread="13.21"/>
                    <measurement group_id="B3" value="30.78" spread="13.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Female</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Male</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Chinese Han</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>China</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>SLE patients</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="47"/>
                    <measurement group_id="B3" value="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Adverse Reaction (Leucopenia)</title>
        <description>The count of white cells &lt; 4.0 × 10ˆ9/L in SLE patient who received CPA medication was considered as CPA-induced leucopenia.</description>
        <time_frame>one month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Experimental Group</title>
            <description>CPA medication was according to the genotypes of SLE patients.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>CPA medication was according to the traditional experiences.</description>
          </group>
        </group_list>
        <measure>
          <title>Adverse Reaction (Leucopenia)</title>
          <description>The count of white cells &lt; 4.0 × 10ˆ9/L in SLE patient who received CPA medication was considered as CPA-induced leucopenia.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6" lower_limit="1.76" upper_limit="14.14"/>
                    <measurement group_id="O2" value="19" lower_limit="1.76" upper_limit="14.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Null hypothesis: there is no difference between the control group and experimental group in terms of frequency of leucopenia.(α=0.05） Chi-square test was applied to test the difference. The Chi-square value was 10.08 and the P-value was 0.0015, which indicated that the null hypothesis could be rejected.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.01</p_value>
            <method>Chi-squared</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>4.99</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.76</ci_lower_limit>
            <ci_upper_limit>14.14</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adverse Reaction ( Infection )</title>
        <description>Flu-like symptoms, Upper respiratory tract infection，and the etc.</description>
        <time_frame>one month</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Experimental Group</title>
            <description>CPA medication was according to the genotypes of SLE patients.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>CPA medication was according to the traditional experiences.</description>
          </group>
        </group_list>
        <measure>
          <title>Adverse Reaction ( Infection )</title>
          <description>Flu-like symptoms, Upper respiratory tract infection，and the etc.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="47"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>Chi-squared</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.69</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.01</ci_lower_limit>
            <ci_upper_limit>7.13</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>One month for all the adverse events reporting.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Experimental Group</title>
          <description>Cyclophosphamide (CPA) medication was according to the genotypes of SLE patients.</description>
        </group>
        <group group_id="E2">
          <title>Control Group</title>
          <description>Cyclophosphamide (CPA) medication was according to the traditional experiences.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 10.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="47"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Leucopenia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="47"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>3</frequency_threshold>
        <default_vocab>MedDRA 10.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="47"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="47"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="45"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The sample size is too small to evaluate the significance of the cyclophosphamide (CPA) medication based on genotypes. We need to enroll more SLE patients in the following study.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Lingyan CHEN, Master candidate</name_or_title>
      <organization>School of Pharmaceutical Sciences, Sun Yat-sen University</organization>
      <phone>+8615018706960</phone>
      <email>chlingy@mail2.sysu.edu.cn</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01689350
org study id: 2012ZX09506001-004
nct id: NCT01689350
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to compare the genotype-based personal prescription of
      cyclophosphamide with the traditional prescription.
Cyclophosphamide (CPA) has been one of the most successful therapies for severe Systemic
      lupus erythematosus (SLE). However, cyclophosphamide can cause severe side effects, including
      bone marrow suppression, infection, gastrointestinal reaction, hemorrhagic cystitis, and the
      etc. Significant variation in efficacy and toxicity of CPA has been observed. Since the
      development of applicable therapeutic drug monitoring (TDM) of cyclophosphamide has been
      reported, it will help to improve the efficacy and reduce toxicities in SLE treatment.
      However, the TDM is a passive strategy which usually lags behind the appearance of
      toxicities. Therefore，it is especially crucial to give individuals genotype-based personal
      prescription of cyclophosphamide in order to gain the most effective therapies. Thus, the
      purpose of this study is to compare the genotype-based personal prescription of
      cyclophosphamide with the traditional prescription, in order to verify the efficacy of the
      genotype-based personal prescription.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Adverse Reaction (Leucopenia)
time frame: one month
description: The count of white cells < 4.0 × 10ˆ9/L in SLE patient who received CPA medication was considered as CPA-induced leucopenia.
measure: Adverse Reaction ( Infection )
time frame: one month
description: Flu-like symptoms, Upper respiratory tract infection，and the etc.
arm group label: Control Group
arm group type: No Intervention
description: The cases in control group received traditional therapy that the initial dose of cyclophosphamide (CPA) was 0.2-0.6g/week injection according to clinical experience.
arm group label: Experimental Group
arm group type: Experimental
description: Genetic: Genotype Detection To Genotype cases in the experimental group and divide them into three groups, including extensive metaboliser (EM), intermediate metaboliser (IM) and poor metaboliser (PM),with initial dose of CPA as 0.2g, 0.4g and 0.6g per week by injection, respectively.
intervention type: Genetic
intervention name: Genotype Detection
description: To Genotype cases in the experimental group and divide them into three groups, including extensive metaboliser (EM), intermediate metaboliser (IM) and poor metaboliser (PM).
arm group label: Experimental Group
criteria: 
gender: All
minimum age: 12 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Huang Min, PhD
role: Study Chair
affiliation: Sun Yat-sen University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Sun Yat-sen University
investigator full name: Lingyan Chen
investigator title: Master Graduate Student
mesh term: Lupus Erythematosus, Systemic
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The sample size is too small to evaluate the significance of the cyclophosphamide (CPA) medication based on genotypes. We need to enroll more SLE patients in the following study.
point of contact: 