<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/NCT03249389</url>
  </required_header>
  <id_info>
    <org_study_id>ICM-URC-2014/55</org_study_id>
    <nct_id>NCT03249389</nct_id>
  </id_info>
  <brief_title>Assessing the Changes in Markers of Calcium Vitamin Metabolism of for Breast Cancer Adjuvant (CALCIOBS)</brief_title>
  <acronym>CALCIOBS</acronym>
  <official_title>Study Assessing the Changes in Markers of Calcium Vitamin Metabolism of Patients Taken in Charge by Chemotherapy for Breast Cancer Adjuvant</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut du Cancer de Montpellier - Val d'Aurelle</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut du Cancer de Montpellier - Val d'Aurelle</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to Assess hypercalciuria between J1 of the cure and 1 J1 6 of the cure of&#xD;
      adjuvant chemotherapy in patients receiving conventional adjuvant chemotherapy of breast&#xD;
      cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In view of the absence of data published on the changes of the vitamin and calcium metabolism&#xD;
      in patients of a breast cancer receiving adjuvant chemotherapy combined with corticosteroids&#xD;
      in antiemetic aiming and a basal calcium vitamin deficiency. A non randomized study&#xD;
      evaluating the percentage of change in the vitamin and calcium balance and the occurrence of&#xD;
      a hypercalciuria between initiation and the end of the adjuvant chemotherapy seems necessary,&#xD;
      both from the scientific point of view, but also to estimate the usefulness of these markers&#xD;
      in clinical practice track.&#xD;
&#xD;
      This study is to Assess hypercalciuria between J1 of the cure and 1 J1 6 of the cure of&#xD;
      adjuvant chemotherapy in patients receiving conventional adjuvant chemotherapy of breast&#xD;
      cancer&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2015</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assess the percentage of occurrence of a hypercalciuria</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Assess the percentage of occurrence of a hypercalciuria between the J1 of the cure 1 and day 1 of the 6 of the adjuvant chemotherapy treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assess of vitamin and calcium balance</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>evolution of the different biological markers of vitamin and calcium balance</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">146</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Blood sample</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients will have a blood sample of 20 ml (4 x 5ml) for inclusion, the J1 of each course and at the end of treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Blood sample</intervention_name>
    <description>patients will have a blood sample of 20 ml (4 x 5ml) for inclusion, the J1 of each course and at the end of treatment</description>
    <arm_group_label>Blood sample</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Mammary adenocarcinoma to receive 6 cycles of adjuvant chemotherapy.&#xD;
&#xD;
               -  Performance index according to who less than or equal to 1.&#xD;
&#xD;
               -  Patient older than 18 years and older.&#xD;
&#xD;
               -  Patient affiliated to a social security scheme or beneficiary of an equivalent&#xD;
                  French social protection system&#xD;
&#xD;
               -  The informed consent signed and before any procedures specific to the test&#xD;
                  screening.&#xD;
&#xD;
                    -  Pregnancy test negative for women and a means of contraception for women and&#xD;
                       men of reproductive age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The presence of metastatic disease.&#xD;
&#xD;
               -  Other cancer (except basal-cell skin carcinoma and cancer of the cervix in situ&#xD;
                  treated adequately and curative) treated in the 3 previous years.&#xD;
&#xD;
               -  Contraindications for the calcium and colecalciferol:-severe hypersensitivity to&#xD;
                  vitamin D or calcium supplementation or any of the excipients&#xD;
&#xD;
          -  Pathology and/or conditions causing a hypercalcemia and/or hypercalciuria&#xD;
&#xD;
          -  Calcium lithiasis - tissue calcification&#xD;
&#xD;
          -  Hypervitaminosis D • Presence of significant co-morbidities: Uncontrolled endocrine&#xD;
             disease. Known disorders of the phospho-calcium balance in the last 3 years.&#xD;
             Osteopenia or osteoporosis proven treatment vitamin and calcium.&#xD;
&#xD;
               -  Concomitant treatment with experimental products.&#xD;
&#xD;
               -  Pregnant or nursing&#xD;
&#xD;
               -  Legal incapacity or limited legal capacity. Medical or psychological conditions,&#xD;
                  allowing the subject to complete the study or to sign the consent (art.) L.1121 -&#xD;
                  6, L.1121 - 7, L.1211 - 8, L1211-9).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>William JACOT</last_name>
    <role>Study Chair</role>
    <affiliation>Institut régional du Cancer de Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institut régional du Cancer de Montpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34298</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>August 29, 2016</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>August 14, 2017</last_update_submitted>
  <last_update_submitted_qc>August 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 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>Breast Neoplasms</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/NCT03249389
org study id: ICM-URC-2014/55
nct id: NCT03249389
lead sponsor: 
has dmc: No
This study is to Assess hypercalciuria between J1 of the cure and 1 J1 6 of the cure of
      adjuvant chemotherapy in patients receiving conventional adjuvant chemotherapy of breast
      cancer.
In view of the absence of data published on the changes of the vitamin and calcium metabolism
      in patients of a breast cancer receiving adjuvant chemotherapy combined with corticosteroids
      in antiemetic aiming and a basal calcium vitamin deficiency. A non randomized study
      evaluating the percentage of change in the vitamin and calcium balance and the occurrence of
      a hypercalciuria between initiation and the end of the adjuvant chemotherapy seems necessary,
      both from the scientific point of view, but also to estimate the usefulness of these markers
      in clinical practice track.

      This study is to Assess hypercalciuria between J1 of the cure and 1 J1 6 of the cure of
      adjuvant chemotherapy in patients receiving conventional adjuvant chemotherapy of breast
      cancer
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Assess the percentage of occurrence of a hypercalciuria
time frame: through study completion, an average of 1 year
description: Assess the percentage of occurrence of a hypercalciuria between the J1 of the cure 1 and day 1 of the 6 of the adjuvant chemotherapy treatment
measure: Assess of vitamin and calcium balance
time frame: through study completion, an average of 1 year
description: evolution of the different biological markers of vitamin and calcium balance
arm group label: Blood sample
arm group type: Experimental
description: patients will have a blood sample of 20 ml (4 x 5ml) for inclusion, the J1 of each course and at the end of treatment
intervention type: Biological
intervention name: Blood sample
description: patients will have a blood sample of 20 ml (4 x 5ml) for inclusion, the J1 of each course and at the end of treatment
arm group label: Blood sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: William JACOT
role: Study Chair
affiliation: Institut régional du Cancer de Montpellier
facility: 
country: France
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: No