<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/NCT04501419</url>
  </required_header>
  <id_info>
    <org_study_id>ERC/2019/10/05</org_study_id>
    <secondary_id>18-114</secondary_id>
    <nct_id>NCT04501419</nct_id>
  </id_info>
  <brief_title>Tablet-based Mobile Health Ultrasound for Point-of-care Breast Cancer Diagnosis in Nigeria</brief_title>
  <official_title>Tablet-based Mobile Health Ultrasound for Point-of-care Breast Cancer Diagnosis in Nigeria</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Obafemi Awolowo University Teaching Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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 study is to train Nigerian radiologists to perform ultrasound-guided&#xD;
      breast biopsies on women that present to the hospital with a suspicious breast mass. Before&#xD;
      performing biopsies on patients, the Nigerian radiologists will have already successfully&#xD;
      completed a competency-based mobile health ultrasound-guided breast biopsy-training program.&#xD;
      This program, developed by experts in Nigeria and the United States of America, certifies&#xD;
      that they have the skills required to safely perform these biopsies on patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 5, 2019</start_date>
  <completion_date type="Anticipated">June 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2025</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Accuracy of US-guided breast biopsy in Nigeria compared to reference standard surgical excision</measure>
    <time_frame>12 months</time_frame>
    <description>US-guided breast biopsies accuracy measurements will be reported using surgical pathology as the reference standard. Specifically we will report accuracy, positive predictive value, negative predictive value, sensitivity and specificity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complication rates from US-guided breast biopsy compared to reference values reported in the literature.</measure>
    <time_frame>12 months</time_frame>
    <description>To determine if the complication rate of US-guided breast biopsies performed by the trained Nigerian radiologists is equivalent to reference values reported in the literature.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Trained radiologists</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Trainers will successfully train Nigerian radiologists</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients with a suspicious breast mass</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women that present to the hospital with a suspicious breast mass</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>US-guided breast biopsy</intervention_name>
    <description>During this study, women with undergo an US-guided breast biopsy by a radiologist instead of what is typically performed in Nigerian hospitals, which is either a blind biopsy or surgical excision. US-guided breast biopsy is the standard of care in the United States of America because the accuracy is better than blind biopsy and equal to surgical excision.</description>
    <arm_group_label>Patients with a suspicious breast mass</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ultrasound-guided breast biopsy training program</intervention_name>
    <description>This program, developed by experts in Nigeria and the United States of America, certifies that they have the skills required to safely perform these biopsies on patients</description>
    <arm_group_label>Trained radiologists</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 and older female&#xD;
&#xD;
          -  Breast ultrasound demonstrating a solid mass that is suspicious for cancer, which&#xD;
             would typically undergo either a blind biopsy or surgical excision at the Nigerian&#xD;
             hospital where the patient is seeking diagnosis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants unwilling to sign consent&#xD;
&#xD;
          -  Participants under the age of 18.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Breast cancer</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Adeleye Omisore, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Obafemi Awolowo University Teaching Hospitals</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Adeleye Omisore, MD</last_name>
    <phone>+2348031538004</phone>
    <email>omisoreadeleye@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Elizabeth Sutton, MD</last_name>
    <phone>646-888-5455</phone>
    <email>suttone@mskcc.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Obafemi Awolowo University Teaching Hospitals Complex (OAUTHC)</name>
      <address>
        <city>Ile-Ife</city>
        <country>Nigeria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Adeleye Omisore, MD</last_name>
      <phone>+2348031538004</phone>
      <email>omisoreadeleye@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Nigeria</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>August 9, 2023</last_update_submitted>
  <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast 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/NCT04501419
org study id: ERC/2019/10/05
secondary id: 18-114
nct id: NCT04501419
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to train Nigerian radiologists to perform ultrasound-guided
      breast biopsies on women that present to the hospital with a suspicious breast mass. Before
      performing biopsies on patients, the Nigerian radiologists will have already successfully
      completed a competency-based mobile health ultrasound-guided breast biopsy-training program.
      This program, developed by experts in Nigeria and the United States of America, certifies
      that they have the skills required to safely perform these biopsies on patients.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Accuracy of US-guided breast biopsy in Nigeria compared to reference standard surgical excision
time frame: 12 months
description: US-guided breast biopsies accuracy measurements will be reported using surgical pathology as the reference standard. Specifically we will report accuracy, positive predictive value, negative predictive value, sensitivity and specificity.
measure: Complication rates from US-guided breast biopsy compared to reference values reported in the literature.
time frame: 12 months
description: To determine if the complication rate of US-guided breast biopsies performed by the trained Nigerian radiologists is equivalent to reference values reported in the literature.
arm group label: Trained radiologists
arm group type: Experimental
description: Trainers will successfully train Nigerian radiologists
arm group label: Patients with a suspicious breast mass
arm group type: Experimental
description: Women that present to the hospital with a suspicious breast mass
intervention type: Procedure
intervention name: US-guided breast biopsy
description: During this study, women with undergo an US-guided breast biopsy by a radiologist instead of what is typically performed in Nigerian hospitals, which is either a blind biopsy or surgical excision. US-guided breast biopsy is the standard of care in the United States of America because the accuracy is better than blind biopsy and equal to surgical excision.
arm group label: Patients with a suspicious breast mass
intervention type: Other
intervention name: Ultrasound-guided breast biopsy training program
description: This program, developed by experts in Nigeria and the United States of America, certifies that they have the skills required to safely perform these biopsies on patients
arm group label: Trained radiologists
criteria: 
gender: Female
gender based: Yes
gender description: Breast cancer
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Adeleye Omisore, MD
role: Principal Investigator
affiliation: Obafemi Awolowo University Teaching Hospitals
last name: Adeleye Omisore, MD
phone: +2348031538004
email: omisoreadeleye@yahoo.com
last name: Elizabeth Sutton, MD
phone: 646-888-5455
email: suttone@mskcc.org
facility: 
status: Recruiting
contact: 
country: Nigeria
responsible party type: Sponsor
mesh term: Breast 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.