<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/NCT03231891</url>
  </required_header>
  <id_info>
    <org_study_id>VICC MD 1712</org_study_id>
    <nct_id>NCT03231891</nct_id>
  </id_info>
  <brief_title>Inherited CAncer REgistry</brief_title>
  <acronym>ICARE</acronym>
  <official_title>Inherited CAncer REgistry (ICARE) Initiative</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt-Ingram Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vanderbilt-Ingram Cancer Center</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>
      The purpose of the Inherited CAncer REgistry (ICARE) Initiative is to provide individuals&#xD;
      interested in participating in studies focused on inherited cancer predisposition the&#xD;
      opportunity to enroll in a research registry. Efforts through the registry include, but are&#xD;
      not limited to, contribution of data to observational studies, targeted gene-specific&#xD;
      studies, and education and outreach efforts for both participants and recruiting healthcare&#xD;
      providers. Participants are given the opportunity to learn about and participate in other&#xD;
      efforts for which they may be eligible.&#xD;
&#xD;
      All participants and recruiting healthcare providers receive educational newsletters twice&#xD;
      per year which contain research and clinical updates in the field of cancer genetics.&#xD;
      Providers who recruit patients can also access monthly web-based genetics case conferences&#xD;
      which focus on different topics each month and are generally attended by a guest expert who&#xD;
      provides background information on the topic as well as comments on the case presentations.&#xD;
&#xD;
      Participation in ICARE involves completion of an informed consent form, baseline&#xD;
      questionnaire, follow-up questionnaires every two years, and medical record/tumor releases,&#xD;
      as applicable. There is no cost to participate and all correspondence can be facilitated&#xD;
      through phone, email, or mail.&#xD;
&#xD;
      Enrollment can be completed either through a traditional paper-based consenting method (i.e.&#xD;
      postal mail) or through the online enrollment option available on the ICARE website&#xD;
      (InheritedCancer.net). If you are a patient interested in learning more or a provider&#xD;
      interested in recruiting to ICARE, please visit our website where you may complete an online&#xD;
      contact form requesting a study team member contact you.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 27, 2017</start_date>
  <completion_date type="Anticipated">December 2035</completion_date>
  <primary_completion_date type="Anticipated">December 2034</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>100 Years</target_duration>
  <primary_outcome>
    <measure>Establish and maintain a registry of individuals who are interested in participating in studies of the genetics of cancer and other related investigations.</measure>
    <time_frame>Up to 100 years</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>Cancer</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Collection of blood, saliva/cheek swab, urine, and/or other biological specimens may be&#xD;
      requested from participants. Tissues saved during previous surgeries as part of the patient's&#xD;
      treatment may be requested.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Individuals interested in participating in inherited cancer research studies.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 18 years of age&#xD;
&#xD;
          -  Able and willing to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tuya Pal, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Anne Weidner, MPH</last_name>
    <phone>615-875-2444</phone>
    <email>ICARE@inheritedcancer.net</email>
  </overall_contact>
  <location>
    <facility>
      <name>Vanderbilt-Ingram Cancer Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37212</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anne Weidner, MPH</last_name>
      <phone>615-875-2444</phone>
      <email>ICARE@inheritedcancer.net</email>
    </contact>
    <investigator>
      <last_name>Tuya Pal, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://inheritedcancer.net</url>
    <description>Inherited Cancer Registry (ICARE) Website</description>
  </link>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>March 3, 2023</last_update_submitted>
  <last_update_submitted_qc>March 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt-Ingram Cancer Center</investigator_affiliation>
    <investigator_full_name>Tuya Pal</investigator_full_name>
    <investigator_title>Associate Director for Cancer Health Disparities</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03231891
org study id: VICC MD 1712
nct id: NCT03231891
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the Inherited CAncer REgistry (ICARE) Initiative is to provide individuals
      interested in participating in studies focused on inherited cancer predisposition the
      opportunity to enroll in a research registry. Efforts through the registry include, but are
      not limited to, contribution of data to observational studies, targeted gene-specific
      studies, and education and outreach efforts for both participants and recruiting healthcare
      providers. Participants are given the opportunity to learn about and participate in other
      efforts for which they may be eligible.

      All participants and recruiting healthcare providers receive educational newsletters twice
      per year which contain research and clinical updates in the field of cancer genetics.
      Providers who recruit patients can also access monthly web-based genetics case conferences
      which focus on different topics each month and are generally attended by a guest expert who
      provides background information on the topic as well as comments on the case presentations.

      Participation in ICARE involves completion of an informed consent form, baseline
      questionnaire, follow-up questionnaires every two years, and medical record/tumor releases,
      as applicable. There is no cost to participate and all correspondence can be facilitated
      through phone, email, or mail.

      Enrollment can be completed either through a traditional paper-based consenting method (i.e.
      postal mail) or through the online enrollment option available on the ICARE website
      (InheritedCancer.net). If you are a patient interested in learning more or a provider
      interested in recruiting to ICARE, please visit our website where you may complete an online
      contact form requesting a study team member contact you.
observational model: Cohort
time perspective: Prospective
measure: Establish and maintain a registry of individuals who are interested in participating in studies of the genetics of cancer and other related investigations.
time frame: Up to 100 years
Collection of blood, saliva/cheek swab, urine, and/or other biological specimens may be
      requested from participants. Tissues saved during previous surgeries as part of the patient's
      treatment may be requested.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Tuya Pal, MD
role: Principal Investigator
affiliation: Vanderbilt University Medical Center
last name: Anne Weidner, MPH
phone: 615-875-2444
email: ICARE@inheritedcancer.net
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
url: http://inheritedcancer.net
description: Inherited Cancer Registry (ICARE) Website
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt-Ingram Cancer Center
investigator full name: Tuya Pal
investigator title: Associate Director for Cancer Health Disparities
sharing ipd: Undecided