<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/NCT03032874</url>
  </required_header>
  <id_info>
    <org_study_id>ERC/2013/02/07</org_study_id>
    <nct_id>NCT03032874</nct_id>
  </id_info>
  <brief_title>Community Based Screening for Colorectal Cancer in an Underserved High Risk Population in Nigeria</brief_title>
  <official_title>Colorectal Cancer Control in Low Resource Countries: Results From a Prospective Cohort Study of Patients at High-risk for Colorectal Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Obafemi Awolowo University Teaching Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Memorial Sloan Kettering Cancer Center, New York, USA</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University College Hospital, Nigeria</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Ilorin Teaching Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Obafemi Awolowo University Teaching 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>
      Patient age 45 year old and above who presented with rectal bleeding at three tertiary&#xD;
      hospitals in South West Nigeria were invited for colonoscopy. The clinical information of the&#xD;
      patients and the colonoscopy data were analyzed&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patient age 45 year old and above who presented with rectal bleeding at Obafemi Awolowo&#xD;
      University Teaching Hospitals Complex, Ile Ife, Nigeria, University College Hospital, Ibadan,&#xD;
      Nigeria, and University of Ilorin Teaching Hospital, Ilorin Nigeria were invited for&#xD;
      colonoscopy. Categorical variables were compared using χ2-test or Fisher's exact test while&#xD;
      the Kruskal-Wallis test was used for quantitative variables. Multivariate analysis was&#xD;
      performed using logistic regression model. All statistical tests were two-sided and p-values&#xD;
      below 0.05 were considered statistically significant. Statistical analysis was carried out&#xD;
      using SAS 9.4 and R 3.3.1.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2014</start_date>
  <completion_date type="Actual">July 30, 2016</completion_date>
  <primary_completion_date type="Actual">July 30, 2016</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>To determine colonoscopy polyp and cancer detection rate</measure>
    <time_frame>2 years</time_frame>
    <description>The hypothesis for this study was that colonoscopy surveillance of a high-risk cohort of patients with rectal bleeding would demonstrate that 10-20% of these patients have pre-malignant colorectal polyps(adenomas) or cancers.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To detect colorectal cancer early using symptoms based assessment</measure>
    <time_frame>2 years</time_frame>
    <description>The long-term impact of identifying at risk patients and patients with early stage cancers may be a reduction in mortality from colorectal cancer in low- and middle- income countries</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Training set</arm_group_label>
    <description>All the patients with rectal bleeding who had colonoscopy performed at Obafemi Awolowo University Teaching Hospitals Complex</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Validation set</arm_group_label>
    <description>All the patients with rectal bleeding who had colonoscopy performed at University College Hospital, Ibadan and University of Ilorin Teaching Hospital</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Colonoscopy</intervention_name>
    <description>They all had screening colonoscopy</description>
    <arm_group_label>Training set</arm_group_label>
    <arm_group_label>Validation set</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Colonic polyps and colorectal cancer specimen&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Nigerians with rectal bleeding&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  must be 45-years of age or older&#xD;
&#xD;
          -  has rectal bleeding lasting at least one week&#xD;
&#xD;
          -  has had a complete colonoscopy performed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals with a personal history of inflammatory bowel disease, colorectal polyps,&#xD;
             colorectal adenoma or CRC&#xD;
&#xD;
          -  Individuals with a family history of familial adenomatous polyposis syndromes or other&#xD;
             hereditary polyposis syndromes, hereditary nonpolyposis colorectal cancer&#xD;
&#xD;
          -  Individuals with severe comorbidities that were contraindication to colonoscopy&#xD;
&#xD;
          -  Individuals who had a previous history of colectomy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Endoscopy Unit, Obafemi Awolowo University Teaching Hospitals</name>
      <address>
        <city>Ile Ife</city>
        <state>Osun</state>
        <zip>220005</zip>
        <country>Nigeria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Nigeria</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 25, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>January 27, 2017</last_update_submitted>
  <last_update_submitted_qc>January 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Obafemi Awolowo University Teaching Hospital</investigator_affiliation>
    <investigator_full_name>Olusegun Alatise</investigator_full_name>
    <investigator_title>Consultant Surgeon/Senior Lecturer</investigator_title>
  </responsible_party>
  <keyword>Colorectal cancer</keyword>
  <keyword>Polyps</keyword>
  <keyword>Colonoscopy</keyword>
  <keyword>Rectal bleeding</keyword>
  <keyword>Nigeria</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>Undecided</sharing_ipd>
    <ipd_description>Each request will be review on their merit by the team and approval of the Ethic and Research Committee that approve the study</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/NCT03032874
org study id: ERC/2013/02/07
nct id: NCT03032874
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patient age 45 year old and above who presented with rectal bleeding at three tertiary
      hospitals in South West Nigeria were invited for colonoscopy. The clinical information of the
      patients and the colonoscopy data were analyzed
Patient age 45 year old and above who presented with rectal bleeding at Obafemi Awolowo
      University Teaching Hospitals Complex, Ile Ife, Nigeria, University College Hospital, Ibadan,
      Nigeria, and University of Ilorin Teaching Hospital, Ilorin Nigeria were invited for
      colonoscopy. Categorical variables were compared using χ2-test or Fisher's exact test while
      the Kruskal-Wallis test was used for quantitative variables. Multivariate analysis was
      performed using logistic regression model. All statistical tests were two-sided and p-values
      below 0.05 were considered statistically significant. Statistical analysis was carried out
      using SAS 9.4 and R 3.3.1.
observational model: Cohort
time perspective: Prospective
measure: To determine colonoscopy polyp and cancer detection rate
time frame: 2 years
description: The hypothesis for this study was that colonoscopy surveillance of a high-risk cohort of patients with rectal bleeding would demonstrate that 10-20% of these patients have pre-malignant colorectal polyps(adenomas) or cancers.
measure: To detect colorectal cancer early using symptoms based assessment
time frame: 2 years
description: The long-term impact of identifying at risk patients and patients with early stage cancers may be a reduction in mortality from colorectal cancer in low- and middle- income countries
arm group label: Training set
description: All the patients with rectal bleeding who had colonoscopy performed at Obafemi Awolowo University Teaching Hospitals Complex
arm group label: Validation set
description: All the patients with rectal bleeding who had colonoscopy performed at University College Hospital, Ibadan and University of Ilorin Teaching Hospital
intervention type: Procedure
intervention name: Colonoscopy
description: They all had screening colonoscopy
arm group label: Training set
arm group label: Validation set
Colonic polyps and colorectal cancer specimen
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 45 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Nigeria
responsible party type: Principal Investigator
investigator affiliation: Obafemi Awolowo University Teaching Hospital
investigator full name: Olusegun Alatise
investigator title: Consultant Surgeon/Senior Lecturer
mesh term: Colorectal Neoplasms
sharing ipd: Undecided
ipd description: Each request will be review on their merit by the team and approval of the Ethic and Research Committee that approve the study