<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/NCT03795246</url>
  </required_header>
  <id_info>
    <org_study_id>KSF2-1707</org_study_id>
    <nct_id>NCT03795246</nct_id>
  </id_info>
  <brief_title>Follow-up of Sequential Chemotherapy and Stimulation for Fertility Preservation in Young Patients With Breast Cancer</brief_title>
  <acronym>KSF2</acronym>
  <official_title>Long-term Follow-up of Sequential Chemotherapy and Stimulation for Fertility Preservation in Young Patients Treated for a Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Oscar Lambret</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Oscar Lambret</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>
      Interventional research with low risks and constraints, prospective and monocentric on the&#xD;
      assessment of long-term fertility in patients who underwent an adjuvant sequential&#xD;
      chemotherapy with or without a controled ovarian hyperstimulation. This study follows a&#xD;
      previous one called NCT 01614704.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The patients will have a follow-up once a year during ten years beginning at the end of their&#xD;
      chemotherapy.&#xD;
&#xD;
      They will have a consultation in oncology consisting of:&#xD;
&#xD;
        -  a clinical exam,&#xD;
&#xD;
        -  a collection and follow-up of oncological data&#xD;
&#xD;
        -  a collection of ongoing cancer treatments&#xD;
&#xD;
      and a consultation in gynecology consisting of:&#xD;
&#xD;
        -  a pelvic ultrasound scan (for AFC: Antral Follicle Count)&#xD;
&#xD;
        -  a biological test (FSH, LH, E2, AMH)&#xD;
&#xD;
        -  a collection of gynecological data, contraception and reproductive medicine&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 23, 2018</start_date>
  <completion_date type="Anticipated">January 2028</completion_date>
  <primary_completion_date type="Anticipated">January 2028</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of fertility in terms of cumulative incidence of long-term pregnancy</measure>
    <time_frame>10 years after chemotherapy</time_frame>
    <description>for patients who underwent adjuvant sequential chemotherapy of anthracycline and taxane separately, depending on whether or not they have had Controlled Ovarian Hyperstimulation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of fertility in terms of cumulative incidence of births</measure>
    <time_frame>10 years after chemotherapy</time_frame>
    <description>separately, depending on whether or not they have had Controlled Ovarian Hyperstimulation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of fertility - number of pegnancies spontaneous versus assisted</measure>
    <time_frame>10 years after chemotherapy</time_frame>
    <description>describing the pregnancy type - number of pegnancies spontaneous versus assisted, with ot without the use of frozen gametes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of fertility - pregnancy outcome : miscarriage or single or multiple birth separately</measure>
    <time_frame>10 years after chemotherapy</time_frame>
    <description>describing the pregnancy outcome : miscarriage or single or multiple birth separately, depending on whether or not they have had Controlled Ovarian Hyperstimulation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of the number of patient willing to re-exploit their frozen gametes</measure>
    <time_frame>10 years after chemotherapy</time_frame>
    <description>for patients who have had Controlled Ovarian Hyperstimulation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of the gonadotoxicity of the adjuvant sequential chemotherapy based on anthracyclines and taxanes - AMH rate</measure>
    <time_frame>10 years after chemotherapy</time_frame>
    <description>in terms of AMH rate depending on whether or not they have had Controlled Ovarian Hyperstimulation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of the gonadotoxicity of the adjuvant sequential chemotherapy based on anthracyclines and taxanes - Antral Follicle Count</measure>
    <time_frame>10 years after chemotherapy</time_frame>
    <description>in terms of Antral Follicle Count depending on whether or not they have had Controlled Ovarian Hyperstimulation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Study the long-term carcinologic safety of Controlled Ovarian Hyperstimulation without Letrozole or Tamoxifen co-treatment in terms of survival without relapse</measure>
    <time_frame>After chemotherapy ad until disease progression or death regardless of the cause, up to 10 years after chemotherapy</time_frame>
    <description>Survival without relapse defined by the time frame between the date of surgery and the date of the first recurrence</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">132</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Study Process</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Consultation, Biological Test, Pelvic Ultrasound</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Consultation</intervention_name>
    <description>Consultation in oncology: collection of oncological data and ongoing cancer treatments, clinical exam Consultation in gynecology: collection of gynecological data, contraception and reproductive medicine</description>
    <arm_group_label>Study Process</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Biological Test</intervention_name>
    <description>Blood test:&#xD;
FSH, LH, E2 and AMH&#xD;
4 tubes of 7 mL</description>
    <arm_group_label>Study Process</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pelvic Ultrasound</intervention_name>
    <description>Antral Follicles Count</description>
    <arm_group_label>Study Process</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients included in the study CT 01614704&#xD;
&#xD;
          -  Informed and written consent&#xD;
&#xD;
          -  Affiliated to the National Social Security System&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Impossibility to submit at the study procedures due to geographic, social or mental&#xD;
             reasons&#xD;
&#xD;
          -  Patient deprived of their liberty or under guardianship or tutorship.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Audrey MAILLIEZ, MD</last_name>
    <role>Study Director</role>
    <affiliation>Centre Oscar Lambret</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Christine DECANTER, MD</last_name>
    <role>Study Director</role>
    <affiliation>Centre Hopsitalier Regional Universitaire de Lille - Hôpital Jeanne de Flandre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Oscar Lambret</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>December 31, 2018</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>February 2, 2022</last_update_submitted>
  <last_update_submitted_qc>February 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2022</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/NCT03795246
org study id: KSF2-1707
nct id: NCT03795246
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Interventional research with low risks and constraints, prospective and monocentric on the
      assessment of long-term fertility in patients who underwent an adjuvant sequential
      chemotherapy with or without a controled ovarian hyperstimulation. This study follows a
      previous one called NCT 01614704.
The patients will have a follow-up once a year during ten years beginning at the end of their
      chemotherapy.

      They will have a consultation in oncology consisting of:

        -  a clinical exam,

        -  a collection and follow-up of oncological data

        -  a collection of ongoing cancer treatments

      and a consultation in gynecology consisting of:

        -  a pelvic ultrasound scan (for AFC: Antral Follicle Count)

        -  a biological test (FSH, LH, E2, AMH)

        -  a collection of gynecological data, contraception and reproductive medicine
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Assessment of fertility in terms of cumulative incidence of long-term pregnancy
time frame: 10 years after chemotherapy
description: for patients who underwent adjuvant sequential chemotherapy of anthracycline and taxane separately, depending on whether or not they have had Controlled Ovarian Hyperstimulation
measure: Assessment of fertility in terms of cumulative incidence of births
time frame: 10 years after chemotherapy
description: separately, depending on whether or not they have had Controlled Ovarian Hyperstimulation
measure: Assessment of fertility - number of pegnancies spontaneous versus assisted
time frame: 10 years after chemotherapy
description: describing the pregnancy type - number of pegnancies spontaneous versus assisted, with ot without the use of frozen gametes)
measure: Assessment of fertility - pregnancy outcome : miscarriage or single or multiple birth separately
time frame: 10 years after chemotherapy
description: describing the pregnancy outcome : miscarriage or single or multiple birth separately, depending on whether or not they have had Controlled Ovarian Hyperstimulation
measure: Assessment of the number of patient willing to re-exploit their frozen gametes
time frame: 10 years after chemotherapy
description: for patients who have had Controlled Ovarian Hyperstimulation
measure: Assessment of the gonadotoxicity of the adjuvant sequential chemotherapy based on anthracyclines and taxanes - AMH rate
time frame: 10 years after chemotherapy
description: in terms of AMH rate depending on whether or not they have had Controlled Ovarian Hyperstimulation
measure: Assessment of the gonadotoxicity of the adjuvant sequential chemotherapy based on anthracyclines and taxanes - Antral Follicle Count
time frame: 10 years after chemotherapy
description: in terms of Antral Follicle Count depending on whether or not they have had Controlled Ovarian Hyperstimulation
measure: Study the long-term carcinologic safety of Controlled Ovarian Hyperstimulation without Letrozole or Tamoxifen co-treatment in terms of survival without relapse
time frame: After chemotherapy ad until disease progression or death regardless of the cause, up to 10 years after chemotherapy
description: Survival without relapse defined by the time frame between the date of surgery and the date of the first recurrence
arm group label: Study Process
arm group type: Experimental
description: Consultation, Biological Test, Pelvic Ultrasound
intervention type: Procedure
intervention name: Consultation
description: Consultation in oncology: collection of oncological data and ongoing cancer treatments, clinical exam Consultation in gynecology: collection of gynecological data, contraception and reproductive medicine
arm group label: Study Process
intervention type: Biological
intervention name: Biological Test
description: Blood test:
FSH, LH, E2 and AMH
4 tubes of 7 mL
arm group label: Study Process
intervention type: Procedure
intervention name: Pelvic Ultrasound
description: Antral Follicles Count
arm group label: Study Process
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Audrey MAILLIEZ, MD
role: Study Director
affiliation: Centre Oscar Lambret
last name: Christine DECANTER, MD
role: Study Director
affiliation: Centre Hopsitalier Regional Universitaire de Lille - Hôpital Jeanne de Flandre
facility: 
country: France
responsible party type: Sponsor
mesh term: Breast Neoplasms