<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/NCT04489238</url>
  </required_header>
  <id_info>
    <org_study_id>20-315</org_study_id>
    <nct_id>NCT04489238</nct_id>
  </id_info>
  <brief_title>Collection of Information to Better Understand Young Onset Colorectal Cancer</brief_title>
  <official_title>Young Onset Gastrointestinal Cancer Prospective Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</source>
  <oversight_info>
    <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 this registry study is to create a database-a collection of information-for&#xD;
      better understanding young onset colorectal cancer. Colorectal cancer patients are considered&#xD;
      to have young onset colorectal cancer if they are diagnosed with their cancer before the age&#xD;
      of 50. Researchers will use the information from this database to learn more about how young&#xD;
      onset colorectal cancer may be similar to or different from colorectal cancer that is&#xD;
      diagnosed later in life. Researchers will also use information from the database for current&#xD;
      and future research on young onset colorectal cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 22, 2020</start_date>
  <completion_date type="Anticipated">July 22, 2023</completion_date>
  <primary_completion_date type="Anticipated">July 22, 2023</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Establish a prospective database of patients with Young Onset Colorectal Cancer</measure>
    <time_frame>1 year</time_frame>
    <description>from diagnosis through survivorship</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">666</enrollment>
  <condition>Colorectal Cancer</condition>
  <condition>Colorectal Carcinoma</condition>
  <arm_group>
    <arm_group_label>Young onset Colorectal Cancer Participants</arm_group_label>
    <description>(Stool collection on newly diagnosed patients in this cohort) Participants will include patients under the age of 50 who are diagnosed with colorectal adenocarcinoma.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Average onset Colorectal Cancer Participants</arm_group_label>
    <description>(Stool collection cohort only) 166 colorectal cancer patients 50 year-old or older will serve as controls.&#xD;
Stool collection cohort only.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Risk Factor Questionnaire</intervention_name>
    <description>Participants, both cases and controls, will complete the CYOC risk factor questionnaire, preferably at the time of first visit</description>
    <arm_group_label>Average onset Colorectal Cancer Participants</arm_group_label>
    <arm_group_label>Young onset Colorectal Cancer Participants</arm_group_label>
    <other_name>CYOC Risk Factor Questionnaire</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Potential research subjects will be identified through the Center for Young Onset&#xD;
        Gastrointestinal Cancer, a member of the patient's treatment team, the principal&#xD;
        investigator, or research team at Memorial Sloan Kettering Cancer Center (MSKCC). All study&#xD;
        participants will be recruited from patients under the care of consenting professionals. If&#xD;
        the investigator is a member of the treatment team, s/he will screen their patient's&#xD;
        medical records for suitable research study participants and discuss the study and their&#xD;
        potential for enrolling in the research study. Potential subjects contacted by their&#xD;
        treating physician will be referred to the investigator/research staff of the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Participant Inclusion Criteria for database and questionnaire (YOGI)&#xD;
&#xD;
          -  Histological or cytological diagnosis of gastrointestinal cancer&#xD;
&#xD;
          -  18 - 49 years old at time of consent&#xD;
&#xD;
          -  No Known hereditary CRC or other cancer predisposition syndrome (stool collection&#xD;
             cohort only)&#xD;
&#xD;
          -  No history of inflammatory bowel disease (stool collection cohort only)&#xD;
&#xD;
          -  No prior diagnosis of gastrointestinal cancer (stool collection cohort only)&#xD;
&#xD;
        Participant Inclusion Criteria for database and questionnaire (Controls)&#xD;
&#xD;
          -  Histological or cytological diagnosis of colorectal adenocarcinoma&#xD;
&#xD;
          -  No previous treatment for CRC (including surgery, chemotherapy, immunotherapy or&#xD;
             radiation)&#xD;
&#xD;
          -  Age 50 or older at time of consent&#xD;
&#xD;
          -  No Known hereditary CRC or other cancer predisposition syndrome&#xD;
&#xD;
          -  No history of inflammatory bowel disease&#xD;
&#xD;
          -  No prior diagnosis of CRC&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrea Cercek, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Andrea Cercek, MD</last_name>
    <phone>646-888-4189</phone>
    <email>cerceka@mskcc.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Rona Yaeger, MD</last_name>
    <phone>646-888-5109</phone>
    <email>yaegerr@mskcc.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Basking Ridge (All Protocol Activities)</name>
      <address>
        <city>Basking Ridge</city>
        <state>New Jersey</state>
        <zip>07920</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrea Cercek, MD</last_name>
      <phone>646-888-4189</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Monmouth</name>
      <address>
        <city>Middletown</city>
        <state>New Jersey</state>
        <zip>07748</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrea Cercek, MD</last_name>
      <phone>646-888-4189</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Bergen</name>
      <address>
        <city>Montvale</city>
        <state>New Jersey</state>
        <zip>07645</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrea Cercek, MD</last_name>
      <phone>646-888-4189</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center @ Commack</name>
      <address>
        <city>Commack</city>
        <state>New York</state>
        <zip>11725</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrea Cercek, MD</last_name>
      <phone>646-888-4189</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Westchester</name>
      <address>
        <city>Harrison</city>
        <state>New York</state>
        <zip>10604</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrew Cercek, MD</last_name>
      <phone>646-888-4189</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>MSK at Ralph Lauren</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10035</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrew Cercek, MD</last_name>
      <phone>646-888-4189</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrew Cercek, MD</last_name>
      <phone>646-888-4189</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Nassau</name>
      <address>
        <city>Rockville Centre</city>
        <state>New York</state>
        <zip>11553</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrea Cercek, MD</last_name>
      <phone>646-888-4189</phone>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mskcc.org</url>
    <description>Memorial Sloan Kettering Cancer Center</description>
  </link>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>July 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>October 5, 2022</last_update_submitted>
  <last_update_submitted_qc>October 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>young onset colorectal cancer</keyword>
  <keyword>colorectal registry</keyword>
  <keyword>20-315</keyword>
  <keyword>Memorial Sloan Kettering Cancer Center</keyword>
  <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>Yes</sharing_ipd>
    <ipd_description>Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.</ipd_description>
  </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/NCT04489238
org study id: 20-315
nct id: NCT04489238
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this registry study is to create a database-a collection of information-for
      better understanding young onset colorectal cancer. Colorectal cancer patients are considered
      to have young onset colorectal cancer if they are diagnosed with their cancer before the age
      of 50. Researchers will use the information from this database to learn more about how young
      onset colorectal cancer may be similar to or different from colorectal cancer that is
      diagnosed later in life. Researchers will also use information from the database for current
      and future research on young onset colorectal cancer.
observational model: Case-Control
time perspective: Prospective
measure: Establish a prospective database of patients with Young Onset Colorectal Cancer
time frame: 1 year
description: from diagnosis through survivorship
arm group label: Young onset Colorectal Cancer Participants
description: (Stool collection on newly diagnosed patients in this cohort) Participants will include patients under the age of 50 who are diagnosed with colorectal adenocarcinoma.
arm group label: Average onset Colorectal Cancer Participants
description: (Stool collection cohort only) 166 colorectal cancer patients 50 year-old or older will serve as controls.
Stool collection cohort only.
intervention type: Other
intervention name: Risk Factor Questionnaire
description: Participants, both cases and controls, will complete the CYOC risk factor questionnaire, preferably at the time of first visit
arm group label: Average onset Colorectal Cancer Participants
arm group label: Young onset Colorectal Cancer Participants
other name: CYOC Risk Factor Questionnaire
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andrea Cercek, MD
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
last name: Andrea Cercek, MD
phone: 646-888-4189
email: cerceka@mskcc.org
last name: Rona Yaeger, MD
phone: 646-888-5109
email: yaegerr@mskcc.org
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United States
url: http://www.mskcc.org
description: Memorial Sloan Kettering Cancer Center
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
sharing ipd: Yes
ipd description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.