<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/NCT03262207</url>
  </required_header>
  <id_info>
    <org_study_id>DESCH AOI 2016</org_study_id>
    <nct_id>NCT03262207</nct_id>
  </id_info>
  <brief_title>Epigenetic Integrity of Spermatozoa in Patients With Germinal Testicular Tumours</brief_title>
  <acronym>GAMETH</acronym>
  <official_title>Epigenetic Integrity of Spermatozoa in Patients With Germinal Testicular Tumours: Potential Risks and Consequences for the Conceptus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Dijon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Dijon</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>
      Recent data suggest that sperm cells carry an epigenetic message during spermatogenesis and&#xD;
      that this message is crucial for the future development of the embryo. This epigenetic&#xD;
      signature is notably represented by methylation of genes subjected to imprinting (GSI) and&#xD;
      the methylation of transposable elements (TE). Data on the maintenance of the imprint and of&#xD;
      the control of TE accompanying human gametogenesis in a context of adult germinal testicular&#xD;
      cancers, seminomas, are extremely fragmentary for tumour tissues and inexistent for gametes.&#xD;
&#xD;
      The aim of this study is to determine whether patients with seminomas in comparison with&#xD;
      fertile men carry a higher risk of presenting epigenetic alterations affecting their gametes.&#xD;
&#xD;
      This study is based on the use of an existing collection of biological samples. 90 samples&#xD;
      will be selected and split into 3 groups:&#xD;
&#xD;
        -  Group 1: 30 sperm samples from patients with seminomatous testicular tumours&#xD;
&#xD;
        -  Group 2: 30 sperm samples from fertile patients&#xD;
&#xD;
        -  Group 3: 30 sperm samples from infertile patients&#xD;
&#xD;
      After treatment of the samples (thawing, cell sorting and removal of cryoprotectants), they&#xD;
      will be analysed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">September 2016</start_date>
  <completion_date type="Anticipated">September 2017</completion_date>
  <primary_completion_date type="Anticipated">September 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Analysis of methylation profiles in paternal genes subjected to imprinting (GSI)</measure>
    <time_frame>at baseline</time_frame>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">90</enrollment>
  <condition>Seminomas</condition>
  <arm_group>
    <arm_group_label>testicular tumours</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>fertile</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>infertile</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Extraction genomic DNA</intervention_name>
    <arm_group_label>fertile</arm_group_label>
    <arm_group_label>infertile</arm_group_label>
    <arm_group_label>testicular tumours</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Analysis of methylation profiles of numerous GSI and TE</intervention_name>
    <arm_group_label>fertile</arm_group_label>
    <arm_group_label>infertile</arm_group_label>
    <arm_group_label>testicular tumours</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Analysis of methylation for the whole genome (sub-population of 15 samples from group 1)</intervention_name>
    <arm_group_label>testicular tumours</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Method of protein detection by immunostaining and flow cytometry</intervention_name>
    <arm_group_label>fertile</arm_group_label>
    <arm_group_label>infertile</arm_group_label>
    <arm_group_label>testicular tumours</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        seminomas&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  biological samples from persons who have provided written consent&#xD;
&#xD;
          -  biological samples of patients over 18 years old&#xD;
&#xD;
          -  with testicular tumours/Fertile/Infertile&#xD;
&#xD;
          -  Matched for age with patients suffering from testicular tumours&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  biological samples of persons without national health insurance cover&#xD;
&#xD;
          -  biological samples from patients with chronic hepatitis B or C or HIV infection&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU Dijon Bourgogne</name>
      <address>
        <city>Dijon</city>
        <zip>21079</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>August 23, 2017</last_update_submitted>
  <last_update_submitted_qc>August 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2017</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>Seminoma</mesh_term>
    <mesh_term>Testicular Neoplasms</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/NCT03262207
org study id: DESCH AOI 2016
nct id: NCT03262207
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Recent data suggest that sperm cells carry an epigenetic message during spermatogenesis and
      that this message is crucial for the future development of the embryo. This epigenetic
      signature is notably represented by methylation of genes subjected to imprinting (GSI) and
      the methylation of transposable elements (TE). Data on the maintenance of the imprint and of
      the control of TE accompanying human gametogenesis in a context of adult germinal testicular
      cancers, seminomas, are extremely fragmentary for tumour tissues and inexistent for gametes.

      The aim of this study is to determine whether patients with seminomas in comparison with
      fertile men carry a higher risk of presenting epigenetic alterations affecting their gametes.

      This study is based on the use of an existing collection of biological samples. 90 samples
      will be selected and split into 3 groups:

        -  Group 1: 30 sperm samples from patients with seminomatous testicular tumours

        -  Group 2: 30 sperm samples from fertile patients

        -  Group 3: 30 sperm samples from infertile patients

      After treatment of the samples (thawing, cell sorting and removal of cryoprotectants), they
      will be analysed.
observational model: Other
time perspective: Other
measure: Analysis of methylation profiles in paternal genes subjected to imprinting (GSI)
time frame: at baseline
arm group label: testicular tumours
arm group label: fertile
arm group label: infertile
intervention type: Other
intervention name: Extraction genomic DNA
arm group label: fertile
arm group label: infertile
arm group label: testicular tumours
intervention type: Other
intervention name: Analysis of methylation profiles of numerous GSI and TE
arm group label: fertile
arm group label: infertile
arm group label: testicular tumours
intervention type: Other
intervention name: Analysis of methylation for the whole genome (sub-population of 15 samples from group 1)
arm group label: testicular tumours
intervention type: Other
intervention name: Method of protein detection by immunostaining and flow cytometry
arm group label: fertile
arm group label: infertile
arm group label: testicular tumours
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Sponsor
mesh term: Seminoma
mesh term: Testicular Neoplasms