xml: <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/NCT05991752</url>
    </required_header>
    <id_info>
      <org_study_id>DR210313</org_study_id>
      <nct_id>NCT05991752</nct_id>
    </id_info>
    <brief_title>Health-Economic Evaluation of Early Diagnosis of Epithalial Ovarian Cancer Recurrence Using the ROMA Score: a Prospective Multicenter Randomized Trial</brief_title>
    <acronym>ROMECO</acronym>
    <official_title>Evaluation médico-économique du Diagnostic précoce Des récidives de Cancer épithélial Ovarien Par le Score ROMA : Essai Prospectif Multicentrique randomisé</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Tours</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Tours</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>
        In this study, we hypothesize that calculating the ROMA score (CA125 + HE4 blood marker&#xD;
        assay) will enable faster, more targeted diagnosis and management of epithelial ovarian&#xD;
        cancer recurrence than the CA125 marker assay alone. This early identification of recurrence&#xD;
        would then improve patients' quality of life, since it would increase the chances of&#xD;
        benefiting from less invasive and less morbid surgery. It would also reduce the cost of&#xD;
        patient management following disease progression. If our hypothesis is confirmed, the results&#xD;
        of this study will enable us to update the recommendations for post-treatment follow-up of&#xD;
        patients in remission from epithelial ovarian cancer, as well as reimbursing the HE4 marker&#xD;
        assay (and thus the calculation of the ROMA score).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 2023</start_date>
    <completion_date type="Anticipated">November 2028</completion_date>
    <primary_completion_date type="Anticipated">November 2028</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Incremental Cost-Utility Ratio (ICUR) expressed as the cost per QALY gained at 36 months of using the ROMA score compared to usual follow-up with the CA-125 test, from the collective perspective.</measure>
      <time_frame>36 months</time_frame>
      <description>QALYs (Quality-Adjusted Life Years) will be estimated from patient responses to the EQ-5D-5L instrument (EuroQol group - 5 Dimensions - 5 levels). The cost evaluation will identify, measure and value all the resources consumed in the production of overall care: hospital and outpatient care, transport, informal care, and social aid services. All consumed resources will be estimated from the collective perspective. QALY and cost data will be used to estimate this within-trial ICUR.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Incremental Cost-Effectiveness Ratio (ICER) expressed as the cost per life-year gained at 36 months of using the ROMA score compared to usual follow-up with the CA-125 test, from the collective perspective.</measure>
      <time_frame>36 months</time_frame>
      <description>Cost and survival data will be used to estimate the within-trial ICER.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incremental Cost-Utility Ratio (ICUR) expressed as the cost per QAPFY gained at 36 months of using the ROMA score compared to usual follow-up with the CA-125 test, from the collective perspective.</measure>
      <time_frame>36 months</time_frame>
      <description>QAPFY (Quality-Adjusted Progression-Free Years) will be estimated using the progression-free survival data and patient responses to the EQ-5D-5L instrument. Cost and QAPFY data will be used to estimate this within-trial ICUR.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Financial impact per year and over a 5-year period of spreading the use of the ROMA score in the routine follow-up of patients for the diagnosis of the first recurrence of epithelial ovarian cancer.</measure>
      <time_frame>per year and over a 5-year period</time_frame>
      <description>The financial impact will be estimated from the French Health Insurance, using a budget impact model.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Characteristics of recurrence between the two groups (i.e. time to recurrence, location and operability)</measure>
      <time_frame>36 months</time_frame>
      <description>Proportion of patients with a first operable recurrence, median interval between randomization and diagnosis of recurrence by imaging or biopsy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Characteristics of treatments for first recurrence (including surgery)</measure>
      <time_frame>36 months</time_frame>
      <description>Proportion of patients with complete surgery without macroscopic residue, without reoperation, proportion of other therapies: chemotherapy/hormone therapy/other therapies</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life of women</measure>
      <time_frame>36 months</time_frame>
      <description>Quality of life assessed by the EORTC QLQ-C30 and EORTC QLQ-OV28 (European Organization for Research and Treatment in Cancer Quality Life Questionnaire) every 4 months for 3 years</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evolution of CA125, HE4 and ROMA score after management of the first recurrence</measure>
      <time_frame>36 months</time_frame>
      <description>Description of the evolution of CA125, HE4 and ROMA score after management of the first recurrence</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Estimation and validation of a mapping function from the specific EORTC QLQ-C30 and EORTC QLQ-OV28 questionnaires to the generic EQ-5D5L questionnaire.</measure>
      <time_frame>36 months</time_frame>
      <description>Deriving the EQ5D-5L score from responses to the EORTC QLQ-C30 and QLQ-OV28 questionnaires in women undergoing post-treatment remission follow-up of epithelial ovarian cancer.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">320</enrollment>
    <condition>Epithelial Ovarian Cancer</condition>
    <arm_group>
      <arm_group_label>ROMA Score</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Experimental group: CA125 and HE4 assays every 4 months for 3 years to assess the ROMA score, in addition to the recommended conventional follow-up.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>CA125 alone</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Control group: CA125 assay alone every 4 months for 3 years, as part of the recommended standard follow-up.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>ROMA score evaluation</intervention_name>
      <description>Every 4 months, for 3 years, patients in the experimental group will done a biological examination based on assessment of the ROMA score (CA125+HE4 assay).</description>
      <arm_group_label>ROMA Score</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Women aged 18 or over and less than 85 years old&#xD;
  &#xD;
            -  With proven FIGO stage I to IV epithelial ovarian cancer (ovary/tumor/peritoneum)&#xD;
  &#xD;
            -  Women in remission after first-line chemotherapy, with a normal CA125 less than 4&#xD;
               months old at study entry (end of first-line chemotherapy).&#xD;
  &#xD;
            -  Woman having completed chemotherapy at least 6 months previously&#xD;
  &#xD;
            -  Written informed consent&#xD;
  &#xD;
            -  French social security&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any physical or psychiatric condition that may interfere with the patient's&#xD;
               cooperation in data collection&#xD;
  &#xD;
            -  Patient with normal CA125 at initial diagnosis of epithelial ovarian cancer&#xD;
  &#xD;
            -  Patient under guardianship&#xD;
  &#xD;
            -  Patient deprived of liberty&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>85 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</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>Ovarian Neoplasms</mesh_term>
      <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05991752
  org study id: DR210313
  nct id: NCT05991752
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  In this study, we hypothesize that calculating the ROMA score (CA125 + HE4 blood marker
        assay) will enable faster, more targeted diagnosis and management of epithelial ovarian
        cancer recurrence than the CA125 marker assay alone. This early identification of recurrence
        would then improve patients' quality of life, since it would increase the chances of
        benefiting from less invasive and less morbid surgery. It would also reduce the cost of
        patient management following disease progression. If our hypothesis is confirmed, the results
        of this study will enable us to update the recommendations for post-treatment follow-up of
        patients in remission from epithelial ovarian cancer, as well as reimbursing the HE4 marker
        assay (and thus the calculation of the ROMA score).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Incremental Cost-Utility Ratio (ICUR) expressed as the cost per QALY gained at 36 months of using the ROMA score compared to usual follow-up with the CA-125 test, from the collective perspective.
  time frame: 36 months
  description: QALYs (Quality-Adjusted Life Years) will be estimated from patient responses to the EQ-5D-5L instrument (EuroQol group - 5 Dimensions - 5 levels). The cost evaluation will identify, measure and value all the resources consumed in the production of overall care: hospital and outpatient care, transport, informal care, and social aid services. All consumed resources will be estimated from the collective perspective. QALY and cost data will be used to estimate this within-trial ICUR.
  measure: Incremental Cost-Effectiveness Ratio (ICER) expressed as the cost per life-year gained at 36 months of using the ROMA score compared to usual follow-up with the CA-125 test, from the collective perspective.
  time frame: 36 months
  description: Cost and survival data will be used to estimate the within-trial ICER.
  measure: Incremental Cost-Utility Ratio (ICUR) expressed as the cost per QAPFY gained at 36 months of using the ROMA score compared to usual follow-up with the CA-125 test, from the collective perspective.
  time frame: 36 months
  description: QAPFY (Quality-Adjusted Progression-Free Years) will be estimated using the progression-free survival data and patient responses to the EQ-5D-5L instrument. Cost and QAPFY data will be used to estimate this within-trial ICUR.
  measure: Financial impact per year and over a 5-year period of spreading the use of the ROMA score in the routine follow-up of patients for the diagnosis of the first recurrence of epithelial ovarian cancer.
  time frame: per year and over a 5-year period
  description: The financial impact will be estimated from the French Health Insurance, using a budget impact model.
  measure: Characteristics of recurrence between the two groups (i.e. time to recurrence, location and operability)
  time frame: 36 months
  description: Proportion of patients with a first operable recurrence, median interval between randomization and diagnosis of recurrence by imaging or biopsy
  measure: Characteristics of treatments for first recurrence (including surgery)
  time frame: 36 months
  description: Proportion of patients with complete surgery without macroscopic residue, without reoperation, proportion of other therapies: chemotherapy/hormone therapy/other therapies
  measure: Quality of life of women
  time frame: 36 months
  description: Quality of life assessed by the EORTC QLQ-C30 and EORTC QLQ-OV28 (European Organization for Research and Treatment in Cancer Quality Life Questionnaire) every 4 months for 3 years
  measure: Evolution of CA125, HE4 and ROMA score after management of the first recurrence
  time frame: 36 months
  description: Description of the evolution of CA125, HE4 and ROMA score after management of the first recurrence
  measure: Estimation and validation of a mapping function from the specific EORTC QLQ-C30 and EORTC QLQ-OV28 questionnaires to the generic EQ-5D5L questionnaire.
  time frame: 36 months
  description: Deriving the EQ5D-5L score from responses to the EORTC QLQ-C30 and QLQ-OV28 questionnaires in women undergoing post-treatment remission follow-up of epithelial ovarian cancer.
  arm group label: ROMA Score
  arm group type: Experimental
  description: Experimental group: CA125 and HE4 assays every 4 months for 3 years to assess the ROMA score, in addition to the recommended conventional follow-up.
  arm group label: CA125 alone
  arm group type: No Intervention
  description: Control group: CA125 assay alone every 4 months for 3 years, as part of the recommended standard follow-up.
  intervention type: Diagnostic Test
  intervention name: ROMA score evaluation
  description: Every 4 months, for 3 years, patients in the experimental group will done a biological examination based on assessment of the ROMA score (CA125+HE4 assay).
  arm group label: ROMA Score
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: 18 Years
  maximum age: 85 Years
  healthy volunteers: No
  responsible party type: Sponsor
  mesh term: Ovarian Neoplasms
  mesh term: Carcinoma, Ovarian Epithelial