<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/NCT02243267</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00064405</org_study_id>
    <nct_id>NCT02243267</nct_id>
  </id_info>
  <brief_title>GI SPORE Colon Biosample Protocol</brief_title>
  <official_title>Biospecimens for the Diagnosis, Treatment and Prevention of Colorectal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators are creating a data and specimen repository to study causes , early&#xD;
      detection, prevention and treatment of colon and rectal cancer. The investigators are&#xD;
      collecting data and specimens (blood, stool, urine and tissue) from people who have colon or&#xD;
      rectal cancer, or who are risk for developing colorectal cancer or had normal colonoscopies.&#xD;
      Data and samples are held in the repository until there are enough to be used for a large&#xD;
      study or until there are new techniques that can be used to test them. The GI SPORE Program&#xD;
      at the University of Michigan maintains a repository of specimens for colorectal diseases&#xD;
      that the investigators hope will help fuel new research. The investigators hope that this&#xD;
      work may lead to new treatments or earlier detection of colorectal cancer or improved&#xD;
      diagnosis and treatment of other colon and rectal diseases.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">August 31, 2017</completion_date>
  <primary_completion_date type="Actual">August 31, 2017</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>New Biomarker for colon cancer detection</measure>
    <time_frame>6 years</time_frame>
    <description>To create a longitudinal biorepository from individuals with colorectal cancer, those who are high risk for developing colorectal cancer, and screened, endoscopically normal controls including a reference set of well annotated, pathologically confirmed tissue, plasma, serum, and white blood cell biosamples and corresponding demographic, risk, and clinical treatment data for improved colon cancer detection.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Response to Treatment</measure>
    <time_frame>6 years</time_frame>
    <description>To create a longitudinal biorepository from individuals with colorectal cancer, those who are high risk for developing colorectal cancer, and screened, endoscopically normal controls including a reference set of well annotated, pathologically confirmed tissue, plasma, serum, and white blood cell biosamples and corresponding demographic, risk, and clinical treatment data for improved colon cancer detection.</description>
  </primary_outcome>
  <enrollment type="Actual">115</enrollment>
  <condition>Colon Cancer</condition>
  <condition>Rectal Cancer</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>sample collection</intervention_name>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum Plasma Buffy Coat Tissue Stool Urine&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients of the University of Michigan Health System&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        5.2 General Eligibility Criteria 5.2.1 Overall Inclusion&#xD;
&#xD;
          1. Adults 18 years of age or older&#xD;
&#xD;
          2. Willing to sign informed consent.&#xD;
&#xD;
          3. Able to tolerate removal of up to 50 ml of blood&#xD;
&#xD;
        5.2.2 Overall Exclusion Criteria&#xD;
&#xD;
          1. Pregnant, lactating&#xD;
&#xD;
          2. Unable to understand English&#xD;
&#xD;
          3. Known HIV/AIDS or Hepatitis C&#xD;
&#xD;
        5.3 Disease or Control Specific Eligibility Criteria 5.3.1 Unaffected Healthy Individuals&#xD;
        (Healthy Controls)&#xD;
&#xD;
          1. No prior colorectal neoplasia&#xD;
&#xD;
          2. Undergoing colonoscopy in the next 3-4 months OR had an endoscopically normal&#xD;
             colonoscopy within the previous 6 months.&#xD;
&#xD;
          3. Not prepped for colonoscopy at the time of blood draw&#xD;
&#xD;
          4. No personal history of colorectal cancer&#xD;
&#xD;
          5. No personal history of other cancers in the last 5 years (except basal/squamous skin&#xD;
             lesions)&#xD;
&#xD;
        5.3.2 Prior non-invasive colorectal neoplasia (Adenoma surveillance)&#xD;
&#xD;
          1. Personal history of one or more adenomas or sessile serrated polyps in colon&#xD;
&#xD;
          2. Undergoing colonoscopy in the next 3-4 months&#xD;
&#xD;
          3. Not prepped for colonoscopy at the time of blood draw&#xD;
&#xD;
          4. No personal history of colorectal cancer&#xD;
&#xD;
          5. No personal history of other cancers in the last 5 years (except basal/squamous skin&#xD;
             lesions)&#xD;
&#xD;
        5.3.3 New Diagnosis of Colon Adenocarcinoma (untreated, new colon CA)&#xD;
&#xD;
          1. Newly diagnosed colon adenocarcinoma, any stage&#xD;
&#xD;
          2. No treatment received yet&#xD;
&#xD;
          3. Not prepped for colonoscopy or surgery at the time of blood draw&#xD;
&#xD;
        5.3.4 New Diagnosis of Rectal Adenocarcinoma (untreated, new rectal CA)&#xD;
&#xD;
          1. Newly diagnosed rectal adenocarcinoma, any stage&#xD;
&#xD;
          2. No treatment received yet&#xD;
&#xD;
          3. Not prepped for colonoscopy or surgery at the time of blood draw&#xD;
&#xD;
        5.3.5 Colorectal Cancer (less than 5 years ago) (current/recent CRC)&#xD;
&#xD;
          1. Personal history of colorectal adenocarcinoma within the last 5 years&#xD;
&#xD;
          2. Not prepped for colonoscopy at the time of blood draw&#xD;
&#xD;
          3. No personal history of other cancers in the last 5 years (except basal/squamous skin&#xD;
             lesions)&#xD;
&#xD;
        5.3.6 Colorectal Cancer (greater than 5 years ago)(remote history of colorectal cancer)&#xD;
&#xD;
          1. Personal history of colorectal adenocarcinoma greater than 5 years ago&#xD;
&#xD;
          2. Not prepped for colonoscopy at the time of blood draw&#xD;
&#xD;
        5.3.7 Hereditary Cancer syndrome (confirmed or suspected) (genetic risk of colorectal&#xD;
        cancer)&#xD;
&#xD;
          1. Personal or family history which meets clinical criteria for genetic evaluation for a&#xD;
             hereditary cancer syndrome&#xD;
&#xD;
          2. Not prepped for colonoscopy at the time of blood draw&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>September 11, 2014</study_first_submitted>
  <study_first_submitted_qc>September 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <last_update_submitted>November 6, 2017</last_update_submitted>
  <last_update_submitted_qc>November 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Missy Tuck</investigator_full_name>
    <investigator_title>Project manager</investigator_title>
  </responsible_party>
  <keyword>Colon Cancer Colon Cancer Prevention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colonic 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/NCT02243267
org study id: HUM00064405
nct id: NCT02243267
lead sponsor: 
has dmc: No
The investigators are creating a data and specimen repository to study causes , early
      detection, prevention and treatment of colon and rectal cancer. The investigators are
      collecting data and specimens (blood, stool, urine and tissue) from people who have colon or
      rectal cancer, or who are risk for developing colorectal cancer or had normal colonoscopies.
      Data and samples are held in the repository until there are enough to be used for a large
      study or until there are new techniques that can be used to test them. The GI SPORE Program
      at the University of Michigan maintains a repository of specimens for colorectal diseases
      that the investigators hope will help fuel new research. The investigators hope that this
      work may lead to new treatments or earlier detection of colorectal cancer or improved
      diagnosis and treatment of other colon and rectal diseases.
observational model: Case-Control
time perspective: Prospective
measure: New Biomarker for colon cancer detection
time frame: 6 years
description: To create a longitudinal biorepository from individuals with colorectal cancer, those who are high risk for developing colorectal cancer, and screened, endoscopically normal controls including a reference set of well annotated, pathologically confirmed tissue, plasma, serum, and white blood cell biosamples and corresponding demographic, risk, and clinical treatment data for improved colon cancer detection.
measure: Response to Treatment
time frame: 6 years
description: To create a longitudinal biorepository from individuals with colorectal cancer, those who are high risk for developing colorectal cancer, and screened, endoscopically normal controls including a reference set of well annotated, pathologically confirmed tissue, plasma, serum, and white blood cell biosamples and corresponding demographic, risk, and clinical treatment data for improved colon cancer detection.
intervention type: Other
intervention name: sample collection
Serum Plasma Buffy Coat Tissue Stool Urine
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Missy Tuck
investigator title: Project manager
mesh term: Colonic Neoplasms