<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/NCT01726322</url>
  </required_header>
  <id_info>
    <org_study_id>CTRIAL-IE (ICORG) 10-16</org_study_id>
    <nct_id>NCT01726322</nct_id>
  </id_info>
  <brief_title>Ovarian Reserve in Premenopausal Breast Cancer</brief_title>
  <official_title>A Study to Determine Alteration of Hormone Levels in Premenopausal Patients Receiving Adjuvant or Neo-adjuvant Chemotherapy for Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cancer Trials Ireland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cancer Trials Ireland</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>
      This is a translational, mutlicentre study. The aim of this study is to determine whether&#xD;
      pre-treatment levels of hormones predict ovarian follicular reserve post adjuvant or&#xD;
      neoadjuvant chemotherapy for breast cancer and chemotherapy induced amenorrhea.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is proposed that levels of AMH and inhibin A and B measured will give an indication of the&#xD;
      residual ovarian reserve in women with breast cancer treated with chemotherapy. In addition,&#xD;
      AMH might give an indication of the possible efficacy of GNRH agonists in fertility&#xD;
      preservation and the effect on ovarian follicular reserve using different adjuvant&#xD;
      chemotherapy regimens. Those likely to be offered GNRH agonists are younger women with no&#xD;
      children and a wish to have some in the future. Older women who have completed their families&#xD;
      are less likely to be offered a GNRH agonist.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    As per the HRBs new funding model, HRBs investment will not support costs associated with&#xD;
    routine patient care or translational studies, biobanks, patient registries and questionnaires.&#xD;
    Therefore, a decision was made to cease further study follow up.&#xD;
  </why_stopped>
  <start_date type="Actual">September 2012</start_date>
  <completion_date type="Actual">July 13, 2020</completion_date>
  <primary_completion_date type="Actual">July 13, 2020</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Alteration of hormone levels in premenopausal patients receiving adjuvant or neo-adjuvant chemotherapy for breast cancer</measure>
    <time_frame>AMH levels will be taken at specified intervals until 3 years post chemotherapy</time_frame>
    <description>To determine alteration of hormone levels in premenopausal patients receiving adjuvant or neo-adjuvant chemotherapy for breast cancer</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparative ovarian toxicity of differing neo-adjuvant/ adjuvant chemotherapy regimens</measure>
    <time_frame>up to 3 years post chemotherapy</time_frame>
    <description>To evaluate the comparative ovarian toxicity of differing neo-adjuvant/ adjuvant chemotherapy regimens</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between CIA and depletion of ovarian follicular reserve.</measure>
    <time_frame>up to 3 years post chemotherapy</time_frame>
    <description>To assess the correlation between CIA and depletion of ovarian follicular reserve.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between changes in hormone levels during chemotherapy and the quality of life of premenopausal breast cancer patients</measure>
    <time_frame>up to 3 years post chemotherapy</time_frame>
    <description>To determine the correlation between changes in hormone levels during chemotherapy and the quality of life of premenopausal breast cancer patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy of GNRH agonists in preservation of ovarian follicles in premenopausal women treated with adjuvant or neo-adjuvant chemotherapy for breast cancer</measure>
    <time_frame>up to 3 years post chemotherapy</time_frame>
    <description>To determine the efficacy of GNRH agonists in preservation of ovarian follicles in premenopausal women treated with adjuvant or neo-adjuvant chemotherapy for breast cancer (administration of GNRH agonists is dependent on the treating oncologist's judgment of the patient's case and prac-tices and is not to be influenced by study participation).</description>
  </secondary_outcome>
  <enrollment type="Actual">216</enrollment>
  <condition>Premenopausal Breast Cancer</condition>
  <condition>Breast Cancer</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood, salivary samples and hair samples.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Premenopausal breast cancer patients who are to receive chemotherapy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Documented histological diagnosis of invasive breast cancer&#xD;
&#xD;
          2. Patient due to be treated with chemotherapy (neoadjuvant or adjuvant)*&#xD;
&#xD;
          3. Female patients aged between 18 and 50 years&#xD;
&#xD;
          4. Premenopausal status as defined by a hormone profile within the pre-menopausal range&#xD;
             as defined by local lab&#xD;
&#xD;
             OR The patient's last menstrual period had to be within the last 180 days&#xD;
&#xD;
             OR An IUD is used for contraception.&#xD;
&#xD;
          5. Ability to provide written informed consent&#xD;
&#xD;
               -  Patients treated with GNRH agonist or adjuvant Herceptin or participating in&#xD;
                  other clinical trials are also eligible&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with hypothalamic/pituitary disorder&#xD;
&#xD;
          2. History of ovarian tumour&#xD;
&#xD;
          3. Current pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Beacon Hospital</name>
      <address>
        <city>Dublin</city>
        <state>Dublin 18</state>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Our Lady of Lourdes Hospital</name>
      <address>
        <city>Drogheda</city>
        <state>Louth</state>
        <zip>Co</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bon Secours Hospital</name>
      <address>
        <city>Cork</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cork University Hospital</name>
      <address>
        <city>Cork</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beaumont Hospital</name>
      <address>
        <city>Dublin</city>
        <zip>9</zip>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St James Hospital</name>
      <address>
        <city>Dublin</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Vincent's University Hospital</name>
      <address>
        <city>Dublin</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tallaght University Hospital</name>
      <address>
        <city>Dublin</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sligo General Hospital</name>
      <address>
        <city>Sligo</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Waterford Regional Hospital</name>
      <address>
        <city>Waterford</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ireland</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>November 9, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <last_update_submitted>April 4, 2023</last_update_submitted>
  <last_update_submitted_qc>April 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 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>Breast 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/NCT01726322
org study id: CTRIAL-IE (ICORG) 10-16
nct id: NCT01726322
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a translational, mutlicentre study. The aim of this study is to determine whether
      pre-treatment levels of hormones predict ovarian follicular reserve post adjuvant or
      neoadjuvant chemotherapy for breast cancer and chemotherapy induced amenorrhea.
It is proposed that levels of AMH and inhibin A and B measured will give an indication of the
      residual ovarian reserve in women with breast cancer treated with chemotherapy. In addition,
      AMH might give an indication of the possible efficacy of GNRH agonists in fertility
      preservation and the effect on ovarian follicular reserve using different adjuvant
      chemotherapy regimens. Those likely to be offered GNRH agonists are younger women with no
      children and a wish to have some in the future. Older women who have completed their families
      are less likely to be offered a GNRH agonist.
observational model: Cohort
time perspective: Prospective
measure: Alteration of hormone levels in premenopausal patients receiving adjuvant or neo-adjuvant chemotherapy for breast cancer
time frame: AMH levels will be taken at specified intervals until 3 years post chemotherapy
description: To determine alteration of hormone levels in premenopausal patients receiving adjuvant or neo-adjuvant chemotherapy for breast cancer
measure: Comparative ovarian toxicity of differing neo-adjuvant/ adjuvant chemotherapy regimens
time frame: up to 3 years post chemotherapy
description: To evaluate the comparative ovarian toxicity of differing neo-adjuvant/ adjuvant chemotherapy regimens
measure: Correlation between CIA and depletion of ovarian follicular reserve.
time frame: up to 3 years post chemotherapy
description: To assess the correlation between CIA and depletion of ovarian follicular reserve.
measure: Correlation between changes in hormone levels during chemotherapy and the quality of life of premenopausal breast cancer patients
time frame: up to 3 years post chemotherapy
description: To determine the correlation between changes in hormone levels during chemotherapy and the quality of life of premenopausal breast cancer patients
measure: Efficacy of GNRH agonists in preservation of ovarian follicles in premenopausal women treated with adjuvant or neo-adjuvant chemotherapy for breast cancer
time frame: up to 3 years post chemotherapy
description: To determine the efficacy of GNRH agonists in preservation of ovarian follicles in premenopausal women treated with adjuvant or neo-adjuvant chemotherapy for breast cancer (administration of GNRH agonists is dependent on the treating oncologist's judgment of the patient's case and prac-tices and is not to be influenced by study participation).
Blood, salivary samples and hair samples.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Ireland
responsible party type: Sponsor
mesh term: Breast Neoplasms