<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/NCT04464590</url>
  </required_header>
  <id_info>
    <org_study_id>29BRC19.0131</org_study_id>
    <nct_id>NCT04464590</nct_id>
  </id_info>
  <brief_title>Interest of a Systematic One-year Monitoring by 18F-FDG PET-CT</brief_title>
  <acronym>LYMPHOTEP1</acronym>
  <official_title>Interest of a Systematic One-year Monitoring by 18F-FDG PET-CT of Patients in Complete Remission of Malignant Lymphoma</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>Yes</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>
      In the study, we aimed to characterize the role of FDG PET/CT surveillance at 12 months of&#xD;
      malignant lymphoma in asymptomatic patients after a first complete remission and to define a&#xD;
      rational follow-up strategy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Most aggressive lymphomas are sensitive to first-line immunochemotherapy and are in first&#xD;
      Complete Remission (CR) with initial therapy. CR significantly decreases the risk of&#xD;
      recurrence and increases survival. However, a cure is not guaranteed and approximately one&#xD;
      third of lymphoma patients have a relapse disease.&#xD;
&#xD;
      FDG PET/CT is a valuable noninvasive tool in the evaluation of lymphomas, especially to&#xD;
      differentiate viable lymphoma and fibrosis or necrosis in residual mass.&#xD;
&#xD;
      The majority of relapses are diagnosed based on clinical symptoms reported by patients. And&#xD;
      the role of FDG PET/CT for routine surveillance of patients after treatment is controversial.&#xD;
&#xD;
      However, many medical centers use routine follow-up FDG PET/CT in addition to physical&#xD;
      examination and laboratory analysis to detect subclinical relapse.&#xD;
&#xD;
      Thus, we can imagine a good timing to routine FDG PET/CT when the tumor burden is small in&#xD;
      the asymptomatic window.&#xD;
&#xD;
      Survival improvement for relapse detected by routine follow-up imaging is not clearly&#xD;
      established compared to diagnosis by clinical symptoms.&#xD;
&#xD;
      Several studies tried to assess the value of follow-up FDG PET/CT but population, type,&#xD;
      timing and duration of surveillance imaging was very heterogeneous.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2009</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2016</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>role of FDG-PET/CT surveillance at 12months of lymphoma in asymptomatic patient in first complete remission</measure>
    <time_frame>one day</time_frame>
    <description>detection rate of relapse at 1 year and at the end of follow-up</description>
  </primary_outcome>
  <primary_outcome>
    <measure>performances FDG-PET/CT 1 year</measure>
    <time_frame>one day</time_frame>
    <description>sensitivity, sensibility, predictive negative value, predictive positive value, accuracy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>overall survival and progression-free survival</measure>
    <time_frame>one day</time_frame>
    <description>as the time from the end of first-line chemotherapy</description>
  </secondary_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>Malignant Lymphoma</condition>
  <condition>Relapsed Non Hodgkin Lymphoma</condition>
  <condition>Relapsed Hodgkin's Disease, Adult</condition>
  <condition>Diagnostic Imaging</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All patients were examined every 3 to 4 months during the first two years, then every 6&#xD;
        months for three years, including physical examination and blood-test.&#xD;
&#xD;
        One group (group 1) of patients received a systematic routine surveillance FDG PET/CT at 12&#xD;
        months (PET/CT1y) according to hematologist team and the other group (group 2) did not&#xD;
        receive routine follow-up FDG PET/CT at 12 months (non PET/CT1y).&#xD;
&#xD;
        None patient was symptomatic the first year. A median follow-up of 24 months at the end of&#xD;
        treatment was required.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  first diagnosis of aggressive lymphoma, complete metabolic remission after a&#xD;
             first-line of chemotherapy, no relapse in the first year after the end of treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  minor patient, pregnant woman, legal protection (legal curatorship / guardianship),&#xD;
             absence of consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>olivier delcroix</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHRU Morvan BREST Nuclear Medicine</affiliation>
  </overall_official>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 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 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>aggressive non-hodgkin lymphoma</keyword>
  <keyword>hodgkin lymphoma</keyword>
  <keyword>FDG-PET/CT</keyword>
  <keyword>follow-up</keyword>
  <keyword>routine surveillance</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, Non-Hodgkin</mesh_term>
    <mesh_term>Hodgkin Disease</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/NCT04464590
org study id: 29BRC19.0131
nct id: NCT04464590
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In the study, we aimed to characterize the role of FDG PET/CT surveillance at 12 months of
      malignant lymphoma in asymptomatic patients after a first complete remission and to define a
      rational follow-up strategy.
Most aggressive lymphomas are sensitive to first-line immunochemotherapy and are in first
      Complete Remission (CR) with initial therapy. CR significantly decreases the risk of
      recurrence and increases survival. However, a cure is not guaranteed and approximately one
      third of lymphoma patients have a relapse disease.

      FDG PET/CT is a valuable noninvasive tool in the evaluation of lymphomas, especially to
      differentiate viable lymphoma and fibrosis or necrosis in residual mass.

      The majority of relapses are diagnosed based on clinical symptoms reported by patients. And
      the role of FDG PET/CT for routine surveillance of patients after treatment is controversial.

      However, many medical centers use routine follow-up FDG PET/CT in addition to physical
      examination and laboratory analysis to detect subclinical relapse.

      Thus, we can imagine a good timing to routine FDG PET/CT when the tumor burden is small in
      the asymptomatic window.

      Survival improvement for relapse detected by routine follow-up imaging is not clearly
      established compared to diagnosis by clinical symptoms.

      Several studies tried to assess the value of follow-up FDG PET/CT but population, type,
      timing and duration of surveillance imaging was very heterogeneous.
observational model: Cohort
time perspective: Retrospective
measure: role of FDG-PET/CT surveillance at 12months of lymphoma in asymptomatic patient in first complete remission
time frame: one day
description: detection rate of relapse at 1 year and at the end of follow-up
measure: performances FDG-PET/CT 1 year
time frame: one day
description: sensitivity, sensibility, predictive negative value, predictive positive value, accuracy
measure: overall survival and progression-free survival
time frame: one day
description: as the time from the end of first-line chemotherapy
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: olivier delcroix
role: Principal Investigator
affiliation: CHRU Morvan BREST Nuclear Medicine
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, Non-Hodgkin
mesh term: Hodgkin Disease