<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/NCT04424615</url>
  </required_header>
  <id_info>
    <org_study_id>IGM</org_study_id>
    <nct_id>NCT04424615</nct_id>
  </id_info>
  <brief_title>Idiopathic Granulomatous Mastitis</brief_title>
  <acronym>IGM</acronym>
  <official_title>Idiopathic Granulomatous Mastitis</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>
      Assessment of incidence, diagnosis and treatment of idiopathic granulomatous mastitis in&#xD;
      Assiut university hospital&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Idiopathic granulomatous mastitis is an uncommon, benign and chronic inflammatory breast&#xD;
      disease that mainly involves women of childbearing age . The disease, was first described by&#xD;
      Kessler and Wollock in 1972 .Although it is a benign condition, it is important from&#xD;
      different points of view: it poses a diagnostic and treatment dilemma , also, it clinically&#xD;
      and mammographically mimics breast cancer, especially inflammatory type . On the other hand,&#xD;
      due to lack of a definitive treatment plan, complications of empiric treatment, such as&#xD;
      allergic reaction to antibiotics and poor cosmetic procedures result in following repeated&#xD;
      surgical interventions which threaten the patients . In fact, the etiology of IGM is unknown&#xD;
      but some factors have been stated including reaction to chemical materials such as oral&#xD;
      contraceptive pills, infectious disease, autoimmune diseases and immunologic response formilk&#xD;
      leakage from the breast's lobule . On the other hand, some conditions such as pregnancy,&#xD;
      breast feeding, hyper prolactinemia, galactorrhea, and alpha 1 antitrypsin deficiency have&#xD;
      been associated with the risk of the disease . Infection with corynebacterium kroppenstedtii&#xD;
      has been suggested but is unconfirmed . The final word about etiology is that although the&#xD;
      cause of the disease is unknown the general consensus is that reproductive age, recent&#xD;
      pregnancy, breast feeding and history of oral contraceptive pills use are the most associated&#xD;
      conditions with the disease, as shown in finding. The most common presenting sign is a&#xD;
      defined hard lump of the breast. As the disease progresses nipple inversion, peau d'orange,&#xD;
      tumorous in duration, ulcer and fistula can occur that can easily be mistaken for cancer .&#xD;
      The most common reported ultrasound (U/S) findings are: an irregular hypo echoic finding that&#xD;
      connects with the tubular hypo echo area and parenchymal heterogeneity and an area of mixed&#xD;
      echo pattern with parenchymal deformity, both of which can lead to diagnosis of malignant&#xD;
      changes . Common findings in mammography imaging are asymmetric diffuse and skin thickness .&#xD;
      As mentioned previously, neither U/S nor mammography can differentiate IGM from malignant or&#xD;
      other benign lesions, especially inflammatory breast cancers . Because of U/S and&#xD;
      mammographic failure, some authors suggested MRI in diagnosis of IGM, but studies have shown&#xD;
      that MRI does not provide additional findings for differentiation of IGM from breast cancer.&#xD;
      In view of the non-definitive clinical and imaging findings, histopathology is the&#xD;
      cornerstone of definitive diagnosis . It must be mentioned that FNA cannot confidently&#xD;
      differentiate IGM and histopathological examination remains as the cornerstone . Some studies&#xD;
      obtained different results in terms of the treatment of these patients that suggested&#xD;
      corticosteroids and methotrexate with surgery or treatment with corticosteroid and&#xD;
      azithromycin, and administration of steroids in lesions in these patients .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 2020</start_date>
  <completion_date type="Anticipated">November 2021</completion_date>
  <primary_completion_date type="Anticipated">October 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>clinical response rate</measure>
    <time_frame>six months</time_frame>
    <description>The clinical response is categorized into ''completely healed,'' ''inadequately healed,'' ''stable,'' ''worsened,'' or ''relapsed'' if the lesions had once healed but symptoms returned.&#xD;
clinical response rate [ Time Frame: six months ] The clinical response is categorized into ''completely healed,'' ''inadequately healed,'' ''stable,'' ''worsened,'' or ''relapsed'' if the lesions had once healed but symptoms returned.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>recurrence rate</measure>
    <time_frame>two years</time_frame>
    <description>granulomatous mastitis recurrence</description>
  </secondary_outcome>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Idiopathic Granulomatous Mastitis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        patients during child bearing period&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1- patients proved idiopathic granulomatous mastitis by histopathological examinaton 2 -&#xD;
        Patients during child bearing period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. - tuberculous mastitis, ductectasi, fat necrosis, fungal infection, and sarcoidosis&#xD;
             were excluded.&#xD;
&#xD;
          2. - post-surgical granulomatous reactions against foreign material&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>sherif bakeer, resident doctor</last_name>
    <phone>01009010275</phone>
    <email>sherif.bak27@gmail.com</email>
  </overall_contact>
  <reference>
    <citation>Bellavia M, Damiano G, Palumbo VD, Spinelli G, Tomasello G, Marrazzo A, Ficarella S, Bruno A, Sammartano A, Fiorentini T, Scio A, Maione C, Lo Monte AI. Granulomatous Mastitis during Chronic Antidepressant Therapy: Is It Possible a Conservative Therapeutic Approach? J Breast Cancer. 2012 Sep;15(3):371-2. doi: 10.4048/jbc.2012.15.3.371. Epub 2012 Sep 28.</citation>
    <PMID>23091553</PMID>
  </reference>
  <reference>
    <citation>Garcia-Rodiguez JA, Pattullo A. Idiopathic granulomatous mastitis: a mimicking disease in a pregnant woman: a case report. BMC Res Notes. 2013 Mar 14;6:95. doi: 10.1186/1756-0500-6-95.</citation>
    <PMID>23497626</PMID>
  </reference>
  <reference>
    <citation>Kalayci TO, Koruyucu MB, Apaydin M, Etit D, Varer M. Idiopathic Granulomatous Mastitis Associated with Erythema Nodosum. Balkan Med J. 2016 Mar;33(2):228-31. doi: 10.5152/balkanmedj.2015.150089. Epub 2016 Mar 1.</citation>
    <PMID>27403395</PMID>
  </reference>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>October 3, 2020</last_update_submitted>
  <last_update_submitted_qc>October 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Sherif M Bakeer</investigator_full_name>
    <investigator_title>head of general surgery department</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mastitis</mesh_term>
    <mesh_term>Granulomatous Mastitis</mesh_term>
  </condition_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/NCT04424615
org study id: IGM
nct id: NCT04424615
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Assessment of incidence, diagnosis and treatment of idiopathic granulomatous mastitis in
      Assiut university hospital
Idiopathic granulomatous mastitis is an uncommon, benign and chronic inflammatory breast
      disease that mainly involves women of childbearing age . The disease, was first described by
      Kessler and Wollock in 1972 .Although it is a benign condition, it is important from
      different points of view: it poses a diagnostic and treatment dilemma , also, it clinically
      and mammographically mimics breast cancer, especially inflammatory type . On the other hand,
      due to lack of a definitive treatment plan, complications of empiric treatment, such as
      allergic reaction to antibiotics and poor cosmetic procedures result in following repeated
      surgical interventions which threaten the patients . In fact, the etiology of IGM is unknown
      but some factors have been stated including reaction to chemical materials such as oral
      contraceptive pills, infectious disease, autoimmune diseases and immunologic response formilk
      leakage from the breast's lobule . On the other hand, some conditions such as pregnancy,
      breast feeding, hyper prolactinemia, galactorrhea, and alpha 1 antitrypsin deficiency have
      been associated with the risk of the disease . Infection with corynebacterium kroppenstedtii
      has been suggested but is unconfirmed . The final word about etiology is that although the
      cause of the disease is unknown the general consensus is that reproductive age, recent
      pregnancy, breast feeding and history of oral contraceptive pills use are the most associated
      conditions with the disease, as shown in finding. The most common presenting sign is a
      defined hard lump of the breast. As the disease progresses nipple inversion, peau d'orange,
      tumorous in duration, ulcer and fistula can occur that can easily be mistaken for cancer .
      The most common reported ultrasound (U/S) findings are: an irregular hypo echoic finding that
      connects with the tubular hypo echo area and parenchymal heterogeneity and an area of mixed
      echo pattern with parenchymal deformity, both of which can lead to diagnosis of malignant
      changes . Common findings in mammography imaging are asymmetric diffuse and skin thickness .
      As mentioned previously, neither U/S nor mammography can differentiate IGM from malignant or
      other benign lesions, especially inflammatory breast cancers . Because of U/S and
      mammographic failure, some authors suggested MRI in diagnosis of IGM, but studies have shown
      that MRI does not provide additional findings for differentiation of IGM from breast cancer.
      In view of the non-definitive clinical and imaging findings, histopathology is the
      cornerstone of definitive diagnosis . It must be mentioned that FNA cannot confidently
      differentiate IGM and histopathological examination remains as the cornerstone . Some studies
      obtained different results in terms of the treatment of these patients that suggested
      corticosteroids and methotrexate with surgery or treatment with corticosteroid and
      azithromycin, and administration of steroids in lesions in these patients .
observational model: Cohort
time perspective: Prospective
measure: clinical response rate
time frame: six months
description: The clinical response is categorized into ''completely healed,'' ''inadequately healed,'' ''stable,'' ''worsened,'' or ''relapsed'' if the lesions had once healed but symptoms returned.
clinical response rate [ Time Frame: six months ] The clinical response is categorized into ''completely healed,'' ''inadequately healed,'' ''stable,'' ''worsened,'' or ''relapsed'' if the lesions had once healed but symptoms returned.
measure: recurrence rate
time frame: two years
description: granulomatous mastitis recurrence
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 10 Years
maximum age: 45 Years
healthy volunteers: No
last name: sherif bakeer, resident doctor
phone: 01009010275
email: sherif.bak27@gmail.com
citation: Bellavia M, Damiano G, Palumbo VD, Spinelli G, Tomasello G, Marrazzo A, Ficarella S, Bruno A, Sammartano A, Fiorentini T, Scio A, Maione C, Lo Monte AI. Granulomatous Mastitis during Chronic Antidepressant Therapy: Is It Possible a Conservative Therapeutic Approach? J Breast Cancer. 2012 Sep;15(3):371-2. doi: 10.4048/jbc.2012.15.3.371. Epub 2012 Sep 28.
PMID: 23091553
citation: Garcia-Rodiguez JA, Pattullo A. Idiopathic granulomatous mastitis: a mimicking disease in a pregnant woman: a case report. BMC Res Notes. 2013 Mar 14;6:95. doi: 10.1186/1756-0500-6-95.
PMID: 23497626
citation: Kalayci TO, Koruyucu MB, Apaydin M, Etit D, Varer M. Idiopathic Granulomatous Mastitis Associated with Erythema Nodosum. Balkan Med J. 2016 Mar;33(2):228-31. doi: 10.5152/balkanmedj.2015.150089. Epub 2016 Mar 1.
PMID: 27403395
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Sherif M Bakeer
investigator title: head of general surgery department
mesh term: Mastitis
mesh term: Granulomatous Mastitis