<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/NCT03026998</url>
  </required_header>
  <id_info>
    <org_study_id>IC 2015-14 DepISCARRH</org_study_id>
    <nct_id>NCT03026998</nct_id>
  </id_info>
  <brief_title>MRI Screening of Second Primary Cancer Occurring Within Radiation Fields After Treatment by External Beam Radiation Therapy for Hereditary Retinoblastoma (DepiSCARRH)</brief_title>
  <acronym>DepiSCARRH</acronym>
  <official_title>MRI Screening of Second Primary Cancer Occurring Within Radiation Fields After Treatment by External Beam Radiation Therapy for Hereditary Retinoblastoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut Curie</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut Curie</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>
      The purpose of this study is to assess the benefit of MR screening for asymptomatic head &amp;&#xD;
      neck (or CNS) second primary cancers occurring in hereditary retinoblastoma patients&#xD;
      previously treated by external beam radiation therapy (EBRT).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with hereditary retinoblastoma treated during infancy by external beam radiation&#xD;
      therapy (EBRT) the risk of second primary cancer occurring within radiation fields is high.&#xD;
      The aim of this study is to depict by MRI secondary tumors as early as possible, before the&#xD;
      occurrence of clinical symptoms. Affected patients will be further managed in a national&#xD;
      expert center with dedicated diagnostic and treatment procedures. However, the benefit of&#xD;
      such management has to be assessed in terms of prognosis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 19, 2017</start_date>
  <completion_date type="Anticipated">March 2034</completion_date>
  <primary_completion_date type="Anticipated">March 2034</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assess the benefit of MR screening for asymptomatic head &amp; neck (or CNS) second primary cancers occurring in hereditary retinoblastoma patients previously treated by external beam radiation therapy (EBRT).</measure>
    <time_frame>Up to 10 years</time_frame>
    <description>Rate of patients with R0-resection quality (versus R1 or R2) among patients with second primary cancer depicted by MRI, with comparison to historical series</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assess the visual prognosis of patients with second primary cancer depicted by MRI</measure>
    <time_frame>Up to 10 year</time_frame>
    <description>Measure of residual visual functions before and after local treatment of the second primary cancer in patients depicted by MRI compared to that patients who the second primary cancer was depicted by clinical symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess the feasibility of the MR screening program.</measure>
    <time_frame>Up to 10 years</time_frame>
    <description>Number of MRI performed for the radiological follow-up for patients agreeing to participate to the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of non tumor detected anomalies with invasive procedures to assess the psychological consequences of the MR screening program</measure>
    <time_frame>Up to 10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess the psychological consequences of the MR screening program by the completion of quality of life questionnaires.</measure>
    <time_frame>Up to 10 years</time_frame>
    <description>- Quality of life questionnaires completed by the patient every year (before MRI) during 10 years.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of depicted second primary cancer.to assess the diagnostic accuracy of MRI.</measure>
    <time_frame>Up to 10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of asymptomatic depicted second primary cancer by MR to assess the diagnostic accuracy of MRI</measure>
    <time_frame>Up to 10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of symptomatic second primary cancer between 2 MRI.to assess the diagnostic accuracy of MRI</measure>
    <time_frame>Up to 10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure of sensibility of MRI to detect second primary cancer</measure>
    <time_frame>Up to 10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure of specificity of MRI to detect second primary cancer</measure>
    <time_frame>Up to 10 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Collection of secondary tumors for future research purpose.</measure>
    <time_frame>up to 10 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">167</enrollment>
  <condition>Hereditary Retinoblastoma</condition>
  <arm_group>
    <arm_group_label>MRI</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>MRI</intervention_name>
    <description>MRI will be performed each year during 10 years.</description>
    <arm_group_label>MRI</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Personal history of hereditary retinoblastoma (i.e., familial history of&#xD;
             retinoblastoma, or bilateral retinoblastoma, or unilateral multifocal retinoblastoma,&#xD;
             or identified germline RB1 mutation or 13q deletion)&#xD;
&#xD;
          -  External beam radiation therapy (EBRT) used for retinoblastoma treatment&#xD;
&#xD;
          -  Age at inclusion greater or equal to 7 years old.&#xD;
&#xD;
          -  Time period between the end of EBRT and inclusion date of 5 years or more&#xD;
&#xD;
          -  Written informed consent signed by patient (or legal representative)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Personal history of non-familial unilateral unifocal retinoblastoma without RB1&#xD;
             germline mutation.&#xD;
&#xD;
          -  Personal history of second primary neoplasm occurring within radiation fields&#xD;
&#xD;
          -  Contraindication for MRI (pacemaker, intraocular metallic foreign body, defibrillators&#xD;
             or other implanted electronic devices, intracranial ferro-magnetic clips) or&#xD;
             associated conditions preventing from MR examination (intraocular prostheses and&#xD;
             implants are not a contraindication for MRI; orthodontic metallic devices are not a&#xD;
             contraindication but might decrease the image quality and should be removed, if&#xD;
             possible)&#xD;
&#xD;
          -  Patients unable to comply with follow-up study requirements, for any geographical,&#xD;
             social or psychological reason&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hervé BRISSE, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NSTITUT CURIE</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Anne JOCHEM</last_name>
    <phone>+33 (0) 56 24 56 01</phone>
    <email>anne.jochem@curie.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Institut Curie</name>
      <address>
        <city>Paris</city>
        <zip>75005</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>HERVE BRISSE, MD</last_name>
      <email>herve.brisse@curie.fr</email>
    </contact>
    <investigator>
      <last_name>Hervé BRISSE, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>November 3, 2020</last_update_submitted>
  <last_update_submitted_qc>November 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>hereditary retinoblastoma,</keyword>
  <keyword>External beam radiation therapy (EBRT)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Retinoblastoma</mesh_term>
    <mesh_term>Neoplasms, Second Primary</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/NCT03026998
org study id: IC 2015-14 DepISCARRH
nct id: NCT03026998
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to assess the benefit of MR screening for asymptomatic head &
      neck (or CNS) second primary cancers occurring in hereditary retinoblastoma patients
      previously treated by external beam radiation therapy (EBRT).
Patients with hereditary retinoblastoma treated during infancy by external beam radiation
      therapy (EBRT) the risk of second primary cancer occurring within radiation fields is high.
      The aim of this study is to depict by MRI secondary tumors as early as possible, before the
      occurrence of clinical symptoms. Affected patients will be further managed in a national
      expert center with dedicated diagnostic and treatment procedures. However, the benefit of
      such management has to be assessed in terms of prognosis.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Assess the benefit of MR screening for asymptomatic head & neck (or CNS) second primary cancers occurring in hereditary retinoblastoma patients previously treated by external beam radiation therapy (EBRT).
time frame: Up to 10 years
description: Rate of patients with R0-resection quality (versus R1 or R2) among patients with second primary cancer depicted by MRI, with comparison to historical series
measure: Assess the visual prognosis of patients with second primary cancer depicted by MRI
time frame: Up to 10 year
description: Measure of residual visual functions before and after local treatment of the second primary cancer in patients depicted by MRI compared to that patients who the second primary cancer was depicted by clinical symptoms.
measure: Assess the feasibility of the MR screening program.
time frame: Up to 10 years
description: Number of MRI performed for the radiological follow-up for patients agreeing to participate to the study.
measure: Number of non tumor detected anomalies with invasive procedures to assess the psychological consequences of the MR screening program
time frame: Up to 10 years
measure: Assess the psychological consequences of the MR screening program by the completion of quality of life questionnaires.
time frame: Up to 10 years
description: - Quality of life questionnaires completed by the patient every year (before MRI) during 10 years.
measure: Number of depicted second primary cancer.to assess the diagnostic accuracy of MRI.
time frame: Up to 10 years
measure: Number of asymptomatic depicted second primary cancer by MR to assess the diagnostic accuracy of MRI
time frame: Up to 10 years
measure: Number of symptomatic second primary cancer between 2 MRI.to assess the diagnostic accuracy of MRI
time frame: Up to 10 years
measure: Measure of sensibility of MRI to detect second primary cancer
time frame: Up to 10 years
measure: Measure of specificity of MRI to detect second primary cancer
time frame: Up to 10 years
measure: Collection of secondary tumors for future research purpose.
time frame: up to 10 years
arm group label: MRI
arm group type: Other
intervention type: Procedure
intervention name: MRI
description: MRI will be performed each year during 10 years.
arm group label: MRI
criteria: 
gender: All
minimum age: 7 Years
maximum age: N/A
healthy volunteers: No
last name: Hervé BRISSE, MD
role: Principal Investigator
affiliation: NSTITUT CURIE
last name: Anne JOCHEM
phone: +33 (0) 56 24 56 01
email: anne.jochem@curie.fr
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Retinoblastoma
mesh term: Neoplasms, Second Primary
sharing ipd: No