<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/NCT04488432</url>
  </required_header>
  <id_info>
    <org_study_id>29BRC19.0137</org_study_id>
    <nct_id>NCT04488432</nct_id>
  </id_info>
  <brief_title>Endocrine, Bone And Metabolic Disorders In Adults After Allogeneic Stem-cell Transplant</brief_title>
  <acronym>ENDOCALLOGREFF</acronym>
  <official_title>Endocrine, Bone And Metabolic Disorders In Adults After Allogeneic Stem-cell Transplant</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Brest</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Brest</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>
      Allogeneic hematopoietic stem cell transplantations (allo-HSCT) is often indicated in&#xD;
      malignant hematologic diseases. Conditioning regimens, used to reduce the tumor burden and to&#xD;
      prevent transplant rejection, are based on chemotherapy alone or combined with total body&#xD;
      irradiation (TBI). Endocrine complications are frequent transplant-related side effects.&#xD;
      Investigators have been well described in children studies but less in adulthood.&#xD;
&#xD;
      The objective of this study is to assess retrospectively endocrine, bone and metabolic&#xD;
      disorders in adult patients, 12 months after allo-HSCT.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients &amp; Methods Inclusion criteria are : patients treated with allo-HSCT from 2006 to 2016&#xD;
      for a malignant hematologic disease; adult and in complete remission at exploration.&#xD;
&#xD;
      Exclusion criteria are : anteriority of brain radiotherapy and prior HSCT.&#xD;
&#xD;
      Twelve months after HSCT, each patient underwent fasting measurement of IGF1, TSH, fT4, FSH,&#xD;
      LH, sex steroids, glycemia, insulin level, and lipid profile. Unless contraindication,&#xD;
      adrenal and growth hormone functions were assessed with insulin hypoglycemia test. A dual&#xD;
      X-ray absorptiometry was also performed.&#xD;
&#xD;
      Investigators will assess the prevalence of endocrine, bone and metabolic disorders 12 months&#xD;
      after allo-HSCT and describe some of their risk factors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 27, 2019</start_date>
  <completion_date type="Actual">November 27, 2019</completion_date>
  <primary_completion_date type="Actual">November 27, 2019</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Adrenal insuffisiency prevalence</measure>
    <time_frame>12 month post-alloHSCT</time_frame>
    <description>insulin hypoglycemia test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hypothyroidism prevalence</measure>
    <time_frame>12 month post-alloHSCT</time_frame>
    <description>fT4, TSH</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Growth hormon Deficiency prevalence</measure>
    <time_frame>12 month post-alloHSCT</time_frame>
    <description>insulin hypoglycemia test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Premature ovarian failure prevalence</measure>
    <time_frame>12 month post-alloHSCT</time_frame>
    <description>FSH, LH, estradiol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of elevated FSH in men</measure>
    <time_frame>12 month post-alloHSCT</time_frame>
    <description>FSH, testosterone</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of low bone mineral density</measure>
    <time_frame>12 month post-alloHSCT</time_frame>
    <description>dual X-ray absorptiometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of obesity</measure>
    <time_frame>12 month post-alloHSCT</time_frame>
    <description>BMI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of dyslipidemia</measure>
    <time_frame>12 month post-alloHSCT</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of hyperglycemia and insulin-resistance</measure>
    <time_frame>12 month post-alloHSCT</time_frame>
    <description>glycemia and HOMA2-IR index</description>
  </secondary_outcome>
  <enrollment type="Actual">45</enrollment>
  <condition>Endocrine System Diseases</condition>
  <condition>Osteoporosis</condition>
  <condition>Metabolic Syndrome</condition>
  <condition>Adrenal Insufficiency</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients treated with allo-HSCT after puberty from 2006 to 2016 in our University Hospital&#xD;
        of Brest, adult at the endocrine exploration.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients treated with allo-HSCT from 2006 to 2016 for a malignant hematologic disease&#xD;
&#xD;
          -  adult and in complete remission at exploration.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  anteriority of brain radiotherapy&#xD;
&#xD;
          -  prior HSCT&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>CHRU de Brest - Endocrinology and Diabetology Department</name>
      <address>
        <city>Brest</city>
        <zip>29200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>September 10, 2020</last_update_submitted>
  <last_update_submitted_qc>September 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoporosis</mesh_term>
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Metabolic Diseases</mesh_term>
    <mesh_term>Adrenal Insufficiency</mesh_term>
    <mesh_term>Endocrine System Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04488432
org study id: 29BRC19.0137
nct id: NCT04488432
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Allogeneic hematopoietic stem cell transplantations (allo-HSCT) is often indicated in
      malignant hematologic diseases. Conditioning regimens, used to reduce the tumor burden and to
      prevent transplant rejection, are based on chemotherapy alone or combined with total body
      irradiation (TBI). Endocrine complications are frequent transplant-related side effects.
      Investigators have been well described in children studies but less in adulthood.

      The objective of this study is to assess retrospectively endocrine, bone and metabolic
      disorders in adult patients, 12 months after allo-HSCT.
Patients & Methods Inclusion criteria are : patients treated with allo-HSCT from 2006 to 2016
      for a malignant hematologic disease; adult and in complete remission at exploration.

      Exclusion criteria are : anteriority of brain radiotherapy and prior HSCT.

      Twelve months after HSCT, each patient underwent fasting measurement of IGF1, TSH, fT4, FSH,
      LH, sex steroids, glycemia, insulin level, and lipid profile. Unless contraindication,
      adrenal and growth hormone functions were assessed with insulin hypoglycemia test. A dual
      X-ray absorptiometry was also performed.

      Investigators will assess the prevalence of endocrine, bone and metabolic disorders 12 months
      after allo-HSCT and describe some of their risk factors.
observational model: Cohort
time perspective: Retrospective
measure: Adrenal insuffisiency prevalence
time frame: 12 month post-alloHSCT
description: insulin hypoglycemia test
measure: Hypothyroidism prevalence
time frame: 12 month post-alloHSCT
description: fT4, TSH
measure: Growth hormon Deficiency prevalence
time frame: 12 month post-alloHSCT
description: insulin hypoglycemia test
measure: Premature ovarian failure prevalence
time frame: 12 month post-alloHSCT
description: FSH, LH, estradiol
measure: Prevalence of elevated FSH in men
time frame: 12 month post-alloHSCT
description: FSH, testosterone
measure: Prevalence of low bone mineral density
time frame: 12 month post-alloHSCT
description: dual X-ray absorptiometry
measure: Prevalence of obesity
time frame: 12 month post-alloHSCT
description: BMI
measure: Prevalence of dyslipidemia
time frame: 12 month post-alloHSCT
measure: Prevalence of hyperglycemia and insulin-resistance
time frame: 12 month post-alloHSCT
description: glycemia and HOMA2-IR index
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: 75 Years
facility: 
country: France
responsible party type: Sponsor
mesh term: Osteoporosis
mesh term: Metabolic Syndrome
mesh term: Metabolic Diseases
mesh term: Adrenal Insufficiency
mesh term: Endocrine System Diseases
sharing ipd: No