<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/NCT04451343</url>
  </required_header>
  <id_info>
    <org_study_id>MACHROAPICANCER</org_study_id>
    <nct_id>NCT04451343</nct_id>
  </id_info>
  <brief_title>The Life and Care of Patients With Colorectal Cancer Before Age 65 and Their Kindred</brief_title>
  <acronym>MACHROAPIK</acronym>
  <official_title>The Life and Care of Patients With Colorectal Cancer Before Age 65 and Their Kindred</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Poitiers University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Poitiers University Hospital</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 a context the respect of the autonomy of the patients is important, it is necessary to pay&#xD;
      a sustained attention to the experiences and the lived experience as well of the patients&#xD;
      suffering or in remission of cancer as of their family. It is therefore, for the family, to&#xD;
      deepen the synthesis carried out by the Societal Cancer Observatory which is a societal&#xD;
      observatory of cancer&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 6, 2018</start_date>
  <completion_date type="Actual">September 1, 2021</completion_date>
  <primary_completion_date type="Actual">July 6, 2021</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>Assess the interaction between the care path (surgery, chemotherapy, radiotherapy) and the life course in patients before 65 years old with colorectal cancer</measure>
    <time_frame>2 hours</time_frame>
    <description>semi-structured patients interview</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assess how the patients, their relatives and their family members, face the disease.</measure>
    <time_frame>1 hour</time_frame>
    <description>semi-structured patients interview</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">72</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
    <description>Patients with a diagnosis of colorectal cancer before 65 years.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Family</arm_group_label>
    <description>The spouse and /or children and /or parents of a patient 's diagnosis of colorectal cancer before 65 years.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>biographical interviews</intervention_name>
    <description>A sociologist trained in the sociology of cancer, to enable participants to talk about their experiences and clearly distinguish the experiences of each individual</description>
    <arm_group_label>Family</arm_group_label>
    <arm_group_label>Patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Surviving patients over the age of 18 and diagnosed with invasive CRC, infiltrating&#xD;
        adenocarcinoma of the colon or rectum irrespective of the stage before 65 years old will be&#xD;
        selected in the Poitou-Charentes cancer registry 2 to 5 years after announcement of the&#xD;
        diagnosis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients will be&#xD;
&#xD;
          -  over 18 years old&#xD;
&#xD;
          -  with a diagnosis of CRC before 65 years.&#xD;
&#xD;
          -  able to give their non-opposition and to nominate at least 2 family members who would&#xD;
             be willing to participate in the study&#xD;
&#xD;
        The spouse and / or children and / or parents will be eligible:&#xD;
&#xD;
        if they are at least 18 years old, if they can be considered a caregiver or are&#xD;
        first-degree relatives of the index patient for whom a diagnosis of CRC has been made. .&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under 18 years of age or with a diagnosis of CRC after 65 years.&#xD;
&#xD;
          -  Near a deceased patient or under 18 years old.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Registre du Cancer</name>
      <address>
        <city>Poitiers</city>
        <zip>86021</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>November 7, 2018</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>September 28, 2021</last_update_submitted>
  <last_update_submitted_qc>September 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2021</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>Colorectal 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/NCT04451343
org study id: MACHROAPICANCER
nct id: NCT04451343
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In a context the respect of the autonomy of the patients is important, it is necessary to pay
      a sustained attention to the experiences and the lived experience as well of the patients
      suffering or in remission of cancer as of their family. It is therefore, for the family, to
      deepen the synthesis carried out by the Societal Cancer Observatory which is a societal
      observatory of cancer
observational model: Cohort
time perspective: Prospective
measure: Assess the interaction between the care path (surgery, chemotherapy, radiotherapy) and the life course in patients before 65 years old with colorectal cancer
time frame: 2 hours
description: semi-structured patients interview
measure: Assess how the patients, their relatives and their family members, face the disease.
time frame: 1 hour
description: semi-structured patients interview
arm group label: Patients
description: Patients with a diagnosis of colorectal cancer before 65 years.
arm group label: Family
description: The spouse and /or children and /or parents of a patient 's diagnosis of colorectal cancer before 65 years.
intervention type: Other
intervention name: biographical interviews
description: A sociologist trained in the sociology of cancer, to enable participants to talk about their experiences and clearly distinguish the experiences of each individual
arm group label: Family
arm group label: Patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
sharing ipd: No