<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/NCT03264898</url>
  </required_header>
  <id_info>
    <org_study_id>R01CA215034</org_study_id>
    <nct_id>NCT03264898</nct_id>
  </id_info>
  <brief_title>Comparative Effectiveness of FITs With Colonoscopy</brief_title>
  <official_title>Comparative Effectiveness of Fecal Immunochemical Tests With Optical Colonoscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Iowa</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of North Carolina</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Texas Tech University Health Sciences Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Iowa</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>
      Colorectal cancer is a preventable and/or a treatable cancer, but at least 43% of the United&#xD;
      States population is not up-to-date with screening. Although 90% of colorectal cancer&#xD;
      screening is done using colonoscopy, most other countries use fecal immunochemical tests,&#xD;
      reserving colonoscopy for those with a positive fecal immunochemical test. This project will&#xD;
      provide the foundation for a paradigm shift for colorectal cancer screening in the United&#xD;
      States by identifying how well 5 different FITs work for detecting screening relevant&#xD;
      neoplasia, thus reducing morbidity and mortality for colorectal cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Colorectal cancer (CRC) is the third most common cancer and the third leading cause of cancer&#xD;
      death in both men and women in the U.S., with nearly 50,000 deaths each year. Since CRC&#xD;
      develops over a number of years from precursor lesions called polyps, it is largely&#xD;
      detectable and preventable in early stages. As these polyps become larger, they, like most&#xD;
      CRCs, tend to bleed, which is the rationale for the use of fecal occult blood tests (FOBTs)&#xD;
      to detect both polyps and cancers early, while they are curable. However, early screening and&#xD;
      detection is much less common than it could be, with about 43% of eligible individuals&#xD;
      unscreened. Fecal immunochemical tests (FITs) are a type of FOBT that can be a sensitive,&#xD;
      specific, and low cost alternative to colonoscopy for CRC screening. Modeling studies have&#xD;
      shown that for population screening, a strategy of annual FIT testing from age of 50 to 75&#xD;
      years results in an equal number of life-years gained as compared with colonoscopy every 10&#xD;
      years. However, about 90% of screening in the U.S. is done with colonoscopy, the most&#xD;
      expensive and invasive screening test. FITs are far less costly and largely replacing the&#xD;
      guaiac test in CRC screening programs internationally, where only individuals with positive&#xD;
      results are referred for a colonoscopy. Studies done on FITs in other countries often used&#xD;
      FITs not available in the U.S. or studied high-risk populations; thus, results are not&#xD;
      applicable in the U.S. It is critical to determine the FIT(s) with the best test&#xD;
      characteristics in order to implement successful FIT-based screening programs in this&#xD;
      country.&#xD;
&#xD;
      It is estimated that 24 million more individuals will need to be screened by 2018 to reach&#xD;
      the &quot;80% by 2018&quot; goal set by the National Colorectal Cancer Roundtable. To address this&#xD;
      knowledge gap, investigators propose to compare the test characteristics of three Clinical&#xD;
      Laboratory Improvement Amendments (CLIA)-waived FITs and two automated FITs, using&#xD;
      colonoscopy as the gold standard. The rationale for this proposed study is that, for almost&#xD;
      all of the FITs currently marketed in the U.S., there is no evidence of the accuracy claimed.&#xD;
      Specific aims are: Aim 1: To assess the diagnostic accuracy for advanced colorectal neoplasms&#xD;
      of three of the most commonly used CLIA-waived FITs and two automated FITs, using colonoscopy&#xD;
      as the gold standard.&#xD;
&#xD;
      Aim 2: To evaluate the diagnostic accuracy of two quantitative FITs using receiver operating&#xD;
      characteristic (ROC) analysis. Aim 3: To assess factors associated with false positive and&#xD;
      false negative FIT results for each device.&#xD;
&#xD;
      These findings will provide essential information about FITs with the best test&#xD;
      characteristics for future expanded use of FIT, critically important to achieving the&#xD;
      long-term goal of reducing morbidity and mortality from CRC. FITs are more acceptable to&#xD;
      patients, will allow higher screening rates, and will reduce costs as compared with a&#xD;
      screening strategy based on colonoscopy as the primary initial screening method.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 2, 2017</start_date>
  <completion_date type="Anticipated">July 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2022</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>FIT Result</measure>
    <time_frame>From recruitment of first subject through study completion, an average of 4 years</time_frame>
    <description>Individual FIT results of negative, positive, or invalid</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">3600</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>FIT Group</arm_group_label>
    <description>Fecal immunochemical tests will be completed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Fecal immunochemical test (FIT)</intervention_name>
    <description>FIT is a type of fecal occult blood test that uses antibodies to hemoglobin to detect blood in stool.</description>
    <arm_group_label>FIT Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients being scheduled for screening or surveillance colonoscopies meeting the study&#xD;
        criteria at three academic health centers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  scheduled for a screening or surveillance colonoscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  familial polyposis syndromes: ulcerative colitis or Crohn's disease: or active rectal&#xD;
             bleeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Barcey T Levy, PhD, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Iowa</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Barcey T Levy, PhD, MD</last_name>
    <phone>319-384-7000</phone>
    <email>barcey-levy@uiowa.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jeanette M Daly, PhD</last_name>
    <phone>319-384-8995</phone>
    <email>jeanette-daly@uiowa.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Iowa</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Barcey T Levy, PhD, MD</last_name>
      <phone>319-384-7622</phone>
      <email>barcey-levy@uiowa.edu</email>
    </contact>
    <contact_backup>
      <last_name>Jeanette M Daly, PhD</last_name>
      <phone>319-384-8995</phone>
      <email>jeanette-daly@uiowa.edu</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>University of North Carolina</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Seth Crockett, MD, MPH</last_name>
      <phone>919-966-7151</phone>
      <email>seth_crockett@med.unc.edu</email>
    </contact>
    <contact_backup>
      <last_name>Dan Reuland, MD, MPH</last_name>
      <phone>919-966-2276</phone>
      <email>daniel_reuland@med.unc.edu</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Texas Tech University Health Sciences Center</name>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <zip>79924</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Navkiran Shokar, MD</last_name>
      <phone>915-215-5574</phone>
      <email>navkiran.shokar@ttuhsc.edu</email>
    </contact>
    <contact_backup>
      <last_name>Marc Zuckerman, MD</last_name>
      <phone>915-215-5272</phone>
      <email>marc.zuckerman@ttuhsc.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://nccrt.org/tools/80-percent-by-2018</url>
    <description>National Colorectal Cancer Roundtable. Tools &amp; Resources - 80% by 2018</description>
  </link>
  <reference>
    <citation>Smith RA, Andrews K, Brooks D, DeSantis CE, Fedewa SA, Lortet-Tieulent J, Manassaram-Baptiste D, Brawley OW, Wender RC. Cancer screening in the United States, 2016: A review of current American Cancer Society guidelines and current issues in cancer screening. CA Cancer J Clin. 2016 Mar-Apr;66(2):96-114. doi: 10.3322/caac.21336. Epub 2016 Jan 21.</citation>
    <PMID>26797525</PMID>
  </reference>
  <reference>
    <citation>Kuntz KM, Lansdorp-Vogelaar I, Rutter CM, Knudsen AB, van Ballegooijen M, Savarino JE, Feuer EJ, Zauber AG. A systematic comparison of microsimulation models of colorectal cancer: the role of assumptions about adenoma progression. Med Decis Making. 2011 Jul-Aug;31(4):530-9. doi: 10.1177/0272989X11408730. Epub 2011 Jun 14.</citation>
    <PMID>21673186</PMID>
  </reference>
  <reference>
    <citation>Young GP, Symonds EL, Allison JE, Cole SR, Fraser CG, Halloran SP, Kuipers EJ, Seaman HE. Advances in Fecal Occult Blood Tests: the FIT revolution. Dig Dis Sci. 2015 Mar;60(3):609-22. doi: 10.1007/s10620-014-3445-3. Epub 2014 Dec 10.</citation>
    <PMID>25492500</PMID>
  </reference>
  <reference>
    <citation>Fedewa SA, Sauer AG, Siegel RL, Jemal A. Prevalence of major risk factors and use of screening tests for cancer in the United States. Cancer Epidemiol Biomarkers Prev. 2015 Apr;24(4):637-52. doi: 10.1158/1055-9965.EPI-15-0134.</citation>
    <PMID>25834147</PMID>
  </reference>
  <reference>
    <citation>Robertson DJ, Imperiale TF. Stool Testing for Colorectal Cancer Screening. Gastroenterology. 2015 Oct;149(5):1286-93. doi: 10.1053/j.gastro.2015.05.045. Epub 2015 May 30.</citation>
    <PMID>26033632</PMID>
  </reference>
  <reference>
    <citation>Allison JE. The best screening test for colorectal cancer is the one that gets done well. Gastrointest Endosc. 2010 Feb;71(2):342-5. doi: 10.1016/j.gie.2009.10.032. No abstract available.</citation>
    <PMID>20152313</PMID>
  </reference>
  <reference>
    <citation>Hawley ST, Volk RJ, Krishnamurthy P, Jibaja-Weiss M, Vernon SW, Kneuper S. Preferences for colorectal cancer screening among racially/ethnically diverse primary care patients. Med Care. 2008 Sep;46(9 Suppl 1):S10-6. doi: 10.1097/MLR.0b013e31817d932e.</citation>
    <PMID>18725820</PMID>
  </reference>
  <reference>
    <citation>Wolf RL, Basch CE, Brouse CH, Shmukler C, Shea S. Patient preferences and adherence to colorectal cancer screening in an urban population. Am J Public Health. 2006 May;96(5):809-11. doi: 10.2105/AJPH.2004.049684. Epub 2006 Mar 29.</citation>
    <PMID>16571715</PMID>
  </reference>
  <reference>
    <citation>Xu Y, Levy BT, Daly JM, Bergus GR, Dunkelberg JC. Comparison of patient preferences for fecal immunochemical test or colonoscopy using the analytic hierarchy process. BMC Health Serv Res. 2015 Apr 23;15:175. doi: 10.1186/s12913-015-0841-0.</citation>
    <PMID>25902770</PMID>
  </reference>
  <reference>
    <citation>Zauber AG, Lansdorp-Vogelaar I, Knudsen AB, Wilschut J, van Ballegooijen M, Kuntz KM. Evaluating test strategies for colorectal cancer screening: a decision analysis for the U.S. Preventive Services Task Force. Ann Intern Med. 2008 Nov 4;149(9):659-69. doi: 10.7326/0003-4819-149-9-200811040-00244. Epub 2008 Oct 6.</citation>
    <PMID>18838717</PMID>
  </reference>
  <reference>
    <citation>Zavoral M, Suchanek S, Majek O, Fric P, Minarikova P, Minarik M, Seifert B, Dusek L. Colorectal cancer screening: 20 years of development and recent progress. World J Gastroenterol. 2014 Apr 14;20(14):3825-34. doi: 10.3748/wjg.v20.i14.3825.</citation>
    <PMID>24744575</PMID>
  </reference>
  <reference>
    <citation>Centers for Disease Control and Prevention (CDC). Vital signs: colorectal cancer screening test use--United States, 2012. MMWR Morb Mortal Wkly Rep. 2013 Nov 8;62(44):881-8.</citation>
    <PMID>24196665</PMID>
  </reference>
  <reference>
    <citation>Zavoral M, Suchanek S, Zavada F, Dusek L, Muzik J, Seifert B, Fric P. Colorectal cancer screening in Europe. World J Gastroenterol. 2009 Dec 21;15(47):5907-15. doi: 10.3748/wjg.15.5907.</citation>
    <PMID>20014454</PMID>
  </reference>
  <reference>
    <citation>de Wijkerslooth TR, Stoop EM, Bossuyt PM, Meijer GA, van Ballegooijen M, van Roon AH, Stegeman I, Kraaijenhagen RA, Fockens P, van Leerdam ME, Dekker E, Kuipers EJ. Immunochemical fecal occult blood testing is equally sensitive for proximal and distal advanced neoplasia. Am J Gastroenterol. 2012 Oct;107(10):1570-8. doi: 10.1038/ajg.2012.249. Epub 2012 Jul 31.</citation>
    <PMID>22850431</PMID>
  </reference>
  <reference>
    <citation>Levi Z, Rozen P, Hazazi R, Vilkin A, Waked A, Maoz E, Birkenfeld S, Leshno M, Niv Y. A quantitative immunochemical fecal occult blood test for colorectal neoplasia. Ann Intern Med. 2007 Feb 20;146(4):244-55. doi: 10.7326/0003-4819-146-4-200702200-00003.</citation>
    <PMID>17310048</PMID>
  </reference>
  <reference>
    <citation>Seeff LC, Richards TB, Shapiro JA, Nadel MR, Manninen DL, Given LS, Dong FB, Winges LD, McKenna MT. How many endoscopies are performed for colorectal cancer screening? Results from CDC's survey of endoscopic capacity. Gastroenterology. 2004 Dec;127(6):1670-7. doi: 10.1053/j.gastro.2004.09.051.</citation>
    <PMID>15578503</PMID>
  </reference>
  <reference>
    <citation>Sharara AI, El Reda ZD, Harb AH, Abou Fadel CG, Sarkis FS, Chalhoub JM, Abou Mrad R. The burden of bowel preparations in patients undergoing elective colonoscopy. United European Gastroenterol J. 2016 Apr;4(2):314-8. doi: 10.1177/2050640615594550. Epub 2015 Jul 3.</citation>
    <PMID>27087962</PMID>
  </reference>
  <reference>
    <citation>Imperiale TF, Ransohoff DF, Itzkowitz SH, Levin TR, Lavin P, Lidgard GP, Ahlquist DA, Berger BM. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med. 2014 Apr 3;370(14):1287-97. doi: 10.1056/NEJMoa1311194. Epub 2014 Mar 19.</citation>
    <PMID>24645800</PMID>
  </reference>
  <reference>
    <citation>Levy BT, Bay C, Xu Y, Daly JM, Bergus G, Dunkelberg J, Moss C. Test characteristics of faecal immunochemical tests (FIT) compared with optical colonoscopy. J Med Screen. 2014 Sep;21(3):133-43. doi: 10.1177/0969141314541109. Epub 2014 Jun 23.</citation>
    <PMID>24958730</PMID>
  </reference>
  <reference>
    <citation>Levi Z, Rozen P, Hazazi R, Vilkin A, Waked A, Maoz E, Birkenfeld S, Lieberman N, Klang S, Niv Y. Sensitivity, but not specificity, of a quantitative immunochemical fecal occult blood test for neoplasia is slightly increased by the use of low-dose aspirin, NSAIDs, and anticoagulants. Am J Gastroenterol. 2009 Apr;104(4):933-8. doi: 10.1038/ajg.2009.14. Epub 2009 Mar 17.</citation>
    <PMID>19293792</PMID>
  </reference>
  <reference>
    <citation>Crouse AL, De Koning L, Sadrzadeh SM, Naugler C. Sensitivity and Specificity of Community Fecal Immunotesting Screening for Colorectal Carcinoma in a High-Risk Canadian Population. Arch Pathol Lab Med. 2015 Nov;139(11):1441-5. doi: 10.5858/arpa.2014-0454-OA.</citation>
    <PMID>26516941</PMID>
  </reference>
  <reference>
    <citation>Rozen P, Comaneshter D, Levi Z, Hazazi R, Vilkin A, Maoz E, Birkenfeld S, Niv Y. Cumulative evaluation of a quantitative immunochemical fecal occult blood test to determine its optimal clinical use. Cancer. 2010 May 1;116(9):2115-25. doi: 10.1002/cncr.25012.</citation>
    <PMID>20186820</PMID>
  </reference>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>May 21, 2018</last_update_submitted>
  <last_update_submitted_qc>May 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 22, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Iowa</investigator_affiliation>
    <investigator_full_name>Barcey T. Levy</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </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>Yes</sharing_ipd>
    <ipd_description>Once the key publications are accepted and finalized, de-identified data and the codebook will be made available to anyone with a legitimate request who follows the Data Sharing agreement.</ipd_description>
    <ipd_time_frame>Once study key publications have been accepted and finalized for publication.</ipd_time_frame>
    <ipd_access_criteria>Researchers have to make a formal proposal for data and codebook.</ipd_access_criteria>
  </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/NCT03264898
org study id: R01CA215034
nct id: NCT03264898
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Colorectal cancer is a preventable and/or a treatable cancer, but at least 43% of the United
      States population is not up-to-date with screening. Although 90% of colorectal cancer
      screening is done using colonoscopy, most other countries use fecal immunochemical tests,
      reserving colonoscopy for those with a positive fecal immunochemical test. This project will
      provide the foundation for a paradigm shift for colorectal cancer screening in the United
      States by identifying how well 5 different FITs work for detecting screening relevant
      neoplasia, thus reducing morbidity and mortality for colorectal cancer.
Colorectal cancer (CRC) is the third most common cancer and the third leading cause of cancer
      death in both men and women in the U.S., with nearly 50,000 deaths each year. Since CRC
      develops over a number of years from precursor lesions called polyps, it is largely
      detectable and preventable in early stages. As these polyps become larger, they, like most
      CRCs, tend to bleed, which is the rationale for the use of fecal occult blood tests (FOBTs)
      to detect both polyps and cancers early, while they are curable. However, early screening and
      detection is much less common than it could be, with about 43% of eligible individuals
      unscreened. Fecal immunochemical tests (FITs) are a type of FOBT that can be a sensitive,
      specific, and low cost alternative to colonoscopy for CRC screening. Modeling studies have
      shown that for population screening, a strategy of annual FIT testing from age of 50 to 75
      years results in an equal number of life-years gained as compared with colonoscopy every 10
      years. However, about 90% of screening in the U.S. is done with colonoscopy, the most
      expensive and invasive screening test. FITs are far less costly and largely replacing the
      guaiac test in CRC screening programs internationally, where only individuals with positive
      results are referred for a colonoscopy. Studies done on FITs in other countries often used
      FITs not available in the U.S. or studied high-risk populations; thus, results are not
      applicable in the U.S. It is critical to determine the FIT(s) with the best test
      characteristics in order to implement successful FIT-based screening programs in this
      country.

      It is estimated that 24 million more individuals will need to be screened by 2018 to reach
      the "80% by 2018" goal set by the National Colorectal Cancer Roundtable. To address this
      knowledge gap, investigators propose to compare the test characteristics of three Clinical
      Laboratory Improvement Amendments (CLIA)-waived FITs and two automated FITs, using
      colonoscopy as the gold standard. The rationale for this proposed study is that, for almost
      all of the FITs currently marketed in the U.S., there is no evidence of the accuracy claimed.
      Specific aims are: Aim 1: To assess the diagnostic accuracy for advanced colorectal neoplasms
      of three of the most commonly used CLIA-waived FITs and two automated FITs, using colonoscopy
      as the gold standard.

      Aim 2: To evaluate the diagnostic accuracy of two quantitative FITs using receiver operating
      characteristic (ROC) analysis. Aim 3: To assess factors associated with false positive and
      false negative FIT results for each device.

      These findings will provide essential information about FITs with the best test
      characteristics for future expanded use of FIT, critically important to achieving the
      long-term goal of reducing morbidity and mortality from CRC. FITs are more acceptable to
      patients, will allow higher screening rates, and will reduce costs as compared with a
      screening strategy based on colonoscopy as the primary initial screening method.
observational model: Cohort
time perspective: Prospective
measure: FIT Result
time frame: From recruitment of first subject through study completion, an average of 4 years
description: Individual FIT results of negative, positive, or invalid
arm group label: FIT Group
description: Fecal immunochemical tests will be completed.
intervention type: Device
intervention name: Fecal immunochemical test (FIT)
description: FIT is a type of fecal occult blood test that uses antibodies to hemoglobin to detect blood in stool.
arm group label: FIT Group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: 85 Years
last name: Barcey T Levy, PhD, MD
role: Principal Investigator
affiliation: University of Iowa
last name: Barcey T Levy, PhD, MD
phone: 319-384-7000
email: barcey-levy@uiowa.edu
last name: Jeanette M Daly, PhD
phone: 319-384-8995
email: jeanette-daly@uiowa.edu
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
url: http://nccrt.org/tools/80-percent-by-2018
description: National Colorectal Cancer Roundtable. Tools & Resources - 80% by 2018
citation: Smith RA, Andrews K, Brooks D, DeSantis CE, Fedewa SA, Lortet-Tieulent J, Manassaram-Baptiste D, Brawley OW, Wender RC. Cancer screening in the United States, 2016: A review of current American Cancer Society guidelines and current issues in cancer screening. CA Cancer J Clin. 2016 Mar-Apr;66(2):96-114. doi: 10.3322/caac.21336. Epub 2016 Jan 21.
PMID: 26797525
citation: Kuntz KM, Lansdorp-Vogelaar I, Rutter CM, Knudsen AB, van Ballegooijen M, Savarino JE, Feuer EJ, Zauber AG. A systematic comparison of microsimulation models of colorectal cancer: the role of assumptions about adenoma progression. Med Decis Making. 2011 Jul-Aug;31(4):530-9. doi: 10.1177/0272989X11408730. Epub 2011 Jun 14.
PMID: 21673186
citation: Young GP, Symonds EL, Allison JE, Cole SR, Fraser CG, Halloran SP, Kuipers EJ, Seaman HE. Advances in Fecal Occult Blood Tests: the FIT revolution. Dig Dis Sci. 2015 Mar;60(3):609-22. doi: 10.1007/s10620-014-3445-3. Epub 2014 Dec 10.
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responsible party type: Principal Investigator
investigator affiliation: University of Iowa
investigator full name: Barcey T. Levy
investigator title: Professor
mesh term: Colorectal Neoplasms
sharing ipd: Yes
ipd description: Once the key publications are accepted and finalized, de-identified data and the codebook will be made available to anyone with a legitimate request who follows the Data Sharing agreement.
ipd time frame: Once study key publications have been accepted and finalized for publication.
ipd access criteria: Researchers have to make a formal proposal for data and codebook.