<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/NCT04468438</url>
  </required_header>
  <id_info>
    <org_study_id>Example 3</org_study_id>
    <nct_id>NCT04468438</nct_id>
  </id_info>
  <brief_title>Role of Estrogen in the Flarring up of Lupus Nepheritis</brief_title>
  <official_title>Role of Estrogen in the Flarring up of Lupus Nepheritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</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>
      Role of estrogen in the flarring up of lupus nepheritis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Systemic lupus erythematosus SLE is an autoimmune disease that affects ∼5.5 per 100,000&#xD;
      individuals worldwide . SLE is characterized by loss of tolerance against nuclear&#xD;
      autoantigens, lymphoproliferation, polyclonal autoantibody production, immune complex&#xD;
      disease, and multiorgan tissue inﬂammation. Up to 50% of SLE patients develop some degree of&#xD;
      renal involvement, with up to 20% progressing to end-stage renal disease, depending on racial&#xD;
      background . Lupus nephritis LN is characterized by anti-nuclear Ab production, immune&#xD;
      complex deposition, and immune-mediated kidney damage. Development of LN remains a sign of&#xD;
      poor prognosis and is a signiﬁcant cause of morbidity and mortality . Because 9 of 10 SLE&#xD;
      patients are women, the role of the sex hormones estrogens in this disease is of key&#xD;
      interest. Estrogens signal through two receptors: estrogen receptor a ERa and estrogen&#xD;
      receptor b ERb. In contrast to estrogen receptor b, ERa is found in female reproductive&#xD;
      organs, yet is robustly expressed in kidney, liver, heart, and lungs in males and females,as&#xD;
      well as on most immune cells however the kidney is considered the most estrogenic&#xD;
      nonreproductive organ. The overwhelming female predominance for SLE begins at puberty and&#xD;
      extends to menopause , supporting the concept that estrogens or other reproductive factors&#xD;
      stimulate lupus development. This concept is further evidenced by reports of menstrual cycle&#xD;
      flares of SLE , disease exacerbations by oral contraceptives or estrogen administration , and&#xD;
      induction of lupus by ovulation regimens . Ultraviolet rays has arole in the flarring up SLE.&#xD;
      There is evidence that fibroblasts and blood lymphocytes from SLE patients are hypersensitive&#xD;
      to the cytotoxic effects of UV light radiation&#xD;
&#xD;
      . RNA and protein synthesis is also affected by UV light 18. A study from 1986 found that&#xD;
      people were more likely to menstruate during a new moon, which occurs during the opposite&#xD;
      half of the lunar cycle than the full moon . There are different evolutionary theories&#xD;
      speculating why the human menstrual cycle length evolved to be so close to the lunar cycle in&#xD;
      length. Stories and beliefs connecting the two are also found in various cultures and&#xD;
      mythologies . The terms menstruation and menses even come from Latin and Greek words meaning&#xD;
      month mensis and moon mene&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 1, 2020</start_date>
  <completion_date type="Anticipated">March 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 1, 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>Role af estrogen in flarring up of lupus nepheritis to detect time of pulse therapy</measure>
    <time_frame>one year</time_frame>
    <description>Measurement of estrogen in the first day of menstruation and the14th day of menstruation To intensify treatment during days of menstruation or days of full moon.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Activity of Lupus Nepheritis</condition>
  <arm_group>
    <arm_group_label>50 patients with LN with regular menstrual cycle</arm_group_label>
    <description>1- First group of50 patients with regular menstrual cycle</description>
  </arm_group>
  <arm_group>
    <arm_group_label>50 patients with LN with amenorrhea</arm_group_label>
    <description>2- Second group of 50 patients with amenorrhea.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>serum estrogen and urinary albumin creatinine ratio</intervention_name>
    <description>serum estrogen and urinary albumin creatinine ratio</description>
    <arm_group_label>50 patients with LN with amenorrhea</arm_group_label>
    <arm_group_label>50 patients with LN with regular menstrual cycle</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        female patients at the reproductive age with systemic lupus divided into two groups:&#xD;
&#xD;
          1. First group patients with regular menstrual cycle.&#xD;
&#xD;
          2. Second group patients with amenorrhea.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with SLE complicated with LN.&#xD;
&#xD;
          2. Patients with age more than 18 years old.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1- Pragnancy, lactation. 2- Menpause. 3- Primary amenorrhea. 4- Patients with current&#xD;
             use of oral contraceptive agents. 5- Patients who receive pulse therapy during the&#xD;
             study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>female patients at the reproductive age with systemic lupus</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>hager zanaty, resident doctor</last_name>
    <phone>01091250220</phone>
    <email>hagerzanatyabd@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>samir kamal, Assistant prof</last_name>
    <phone>01062949199</phone>
    <email>samirkotb45@yahoo.com</email>
  </overall_contact_backup>
  <reference>
    <citation>Somers EC, Marder W, Cagnoli P, Lewis EE, DeGuire P, Gordon C, Helmick CG, Wang L, Wing JJ, Dhar JP, Leisen J, Shaltis D, McCune WJ. Population-based incidence and prevalence of systemic lupus erythematosus: the Michigan Lupus Epidemiology and Surveillance program. Arthritis Rheumatol. 2014 Feb;66(2):369-78. doi: 10.1002/art.38238.</citation>
    <PMID>24504809</PMID>
  </reference>
  <reference>
    <citation>Tan DA, Haththotuwa R, Fraser IS. Cultural aspects and mythologies surrounding menstruation and abnormal uterine bleeding. Best Pract Res Clin Obstet Gynaecol. 2017 Apr;40:121-133. doi: 10.1016/j.bpobgyn.2016.09.015. Epub 2016 Oct 26.</citation>
    <PMID>27863914</PMID>
  </reference>
  <reference>
    <citation>Liu Z, Davidson A. Taming lupus-a new understanding of pathogenesis is leading to clinical advances. Nat Med. 2012 Jun 6;18(6):871-82. doi: 10.1038/nm.2752.</citation>
    <PMID>22674006</PMID>
  </reference>
  <reference>
    <citation>Moulton VR, Tsokos GC. Abnormalities of T cell signaling in systemic lupus erythematosus. Arthritis Res Ther. 2011 Mar 17;13(2):207. doi: 10.1186/ar3251.</citation>
    <PMID>21457530</PMID>
  </reference>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>January 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>July 8, 2020</last_update_submitted>
  <last_update_submitted_qc>July 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Hager Zanaty Abdelraouf</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Estrogens</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04468438
org study id: Example 3
nct id: NCT04468438
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Role of estrogen in the flarring up of lupus nepheritis
Systemic lupus erythematosus SLE is an autoimmune disease that affects ∼5.5 per 100,000
      individuals worldwide . SLE is characterized by loss of tolerance against nuclear
      autoantigens, lymphoproliferation, polyclonal autoantibody production, immune complex
      disease, and multiorgan tissue inﬂammation. Up to 50% of SLE patients develop some degree of
      renal involvement, with up to 20% progressing to end-stage renal disease, depending on racial
      background . Lupus nephritis LN is characterized by anti-nuclear Ab production, immune
      complex deposition, and immune-mediated kidney damage. Development of LN remains a sign of
      poor prognosis and is a signiﬁcant cause of morbidity and mortality . Because 9 of 10 SLE
      patients are women, the role of the sex hormones estrogens in this disease is of key
      interest. Estrogens signal through two receptors: estrogen receptor a ERa and estrogen
      receptor b ERb. In contrast to estrogen receptor b, ERa is found in female reproductive
      organs, yet is robustly expressed in kidney, liver, heart, and lungs in males and females,as
      well as on most immune cells however the kidney is considered the most estrogenic
      nonreproductive organ. The overwhelming female predominance for SLE begins at puberty and
      extends to menopause , supporting the concept that estrogens or other reproductive factors
      stimulate lupus development. This concept is further evidenced by reports of menstrual cycle
      flares of SLE , disease exacerbations by oral contraceptives or estrogen administration , and
      induction of lupus by ovulation regimens . Ultraviolet rays has arole in the flarring up SLE.
      There is evidence that fibroblasts and blood lymphocytes from SLE patients are hypersensitive
      to the cytotoxic effects of UV light radiation

      . RNA and protein synthesis is also affected by UV light 18. A study from 1986 found that
      people were more likely to menstruate during a new moon, which occurs during the opposite
      half of the lunar cycle than the full moon . There are different evolutionary theories
      speculating why the human menstrual cycle length evolved to be so close to the lunar cycle in
      length. Stories and beliefs connecting the two are also found in various cultures and
      mythologies . The terms menstruation and menses even come from Latin and Greek words meaning
      month mensis and moon mene
observational model: Cohort
time perspective: Prospective
measure: Role af estrogen in flarring up of lupus nepheritis to detect time of pulse therapy
time frame: one year
description: Measurement of estrogen in the first day of menstruation and the14th day of menstruation To intensify treatment during days of menstruation or days of full moon.
arm group label: 50 patients with LN with regular menstrual cycle
description: 1- First group of50 patients with regular menstrual cycle
arm group label: 50 patients with LN with amenorrhea
description: 2- Second group of 50 patients with amenorrhea.
intervention type: Diagnostic Test
intervention name: serum estrogen and urinary albumin creatinine ratio
description: serum estrogen and urinary albumin creatinine ratio
arm group label: 50 patients with LN with amenorrhea
arm group label: 50 patients with LN with regular menstrual cycle
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: female patients at the reproductive age with systemic lupus
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: hager zanaty, resident doctor
phone: 01091250220
email: hagerzanatyabd@gmail.com
last name: samir kamal, Assistant prof
phone: 01062949199
email: samirkotb45@yahoo.com
citation: Somers EC, Marder W, Cagnoli P, Lewis EE, DeGuire P, Gordon C, Helmick CG, Wang L, Wing JJ, Dhar JP, Leisen J, Shaltis D, McCune WJ. Population-based incidence and prevalence of systemic lupus erythematosus: the Michigan Lupus Epidemiology and Surveillance program. Arthritis Rheumatol. 2014 Feb;66(2):369-78. doi: 10.1002/art.38238.
PMID: 24504809
citation: Tan DA, Haththotuwa R, Fraser IS. Cultural aspects and mythologies surrounding menstruation and abnormal uterine bleeding. Best Pract Res Clin Obstet Gynaecol. 2017 Apr;40:121-133. doi: 10.1016/j.bpobgyn.2016.09.015. Epub 2016 Oct 26.
PMID: 27863914
citation: Liu Z, Davidson A. Taming lupus-a new understanding of pathogenesis is leading to clinical advances. Nat Med. 2012 Jun 6;18(6):871-82. doi: 10.1038/nm.2752.
PMID: 22674006
citation: Moulton VR, Tsokos GC. Abnormalities of T cell signaling in systemic lupus erythematosus. Arthritis Res Ther. 2011 Mar 17;13(2):207. doi: 10.1186/ar3251.
PMID: 21457530
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Hager Zanaty Abdelraouf
investigator title: Principal investigator
mesh term: Estrogens