<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/NCT01661023</url>
  </required_header>
  <id_info>
    <org_study_id>999912174</org_study_id>
    <secondary_id>12-C-N174</secondary_id>
    <nct_id>NCT01661023</nct_id>
  </id_info>
  <brief_title>The Ghana Breast Health Study</brief_title>
  <official_title>A Multidisciplinary Study of Breast Cancer in Ghana</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</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>
      Background:&#xD;
&#xD;
      - Breast cancer is becoming more common in Africa. A higher number of cases appear in women&#xD;
      under age 35 than in the developed world. However, little is known about the factors that may&#xD;
      contribute to breast cancer in Africa. Researchers want to collect information from female&#xD;
      patients in teaching hospitals in Accra and Kumasi, Ghana and to compare this information&#xD;
      with that obtained from healthy women in the general population. These two hospitals treat&#xD;
      most breast cancers in Ghana. The data will provide information regarding factors that&#xD;
      predispose to the development of breast cancer among women in Ghana.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      - To identify and study breast cancer risk factors in women in Ghana.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
        -  Women between 18 and 74 years of age who are diagnosed with breast cancer.&#xD;
&#xD;
        -  Participants will come from teaching hospitals in Accra and Kumasi, Ghana. Women without&#xD;
           breast cancer will be identified from the 2010 Ghanaian Census for comparison purposes&#xD;
&#xD;
      Design:&#xD;
&#xD;
        -  Participants will answer questions about their health and lifestyle.&#xD;
&#xD;
        -  Height, weight, and waist/hip measurements will be collected.&#xD;
&#xD;
        -  Blood and saliva samples will be collected.&#xD;
&#xD;
        -  Participants will be given a collection kit to collect a stool sample.&#xD;
&#xD;
        -  Treatment will not be provided as part of this study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Breast cancer is becoming a more common disease in Africa, with a high proportion of cases&#xD;
      developing among women under age 50. Despite this, there is scant information on predisposing&#xD;
      factors in African populations. We are proposing a multidisciplinary case-control study at&#xD;
      three hospitals in Accra and Kumasi that treat the majority of breast cancers in Ghana. We&#xD;
      have begun this investigation as a pilot endeavor and are seeking approval for continuation&#xD;
      into a full-scale effort, which over the two years following the pilot will result in a total&#xD;
      of approximately 2,000 interviewed cases and 2,000 population controls. Tumor tissue samples&#xD;
      are being sought from cases in order to classify them into subtypes (including triple&#xD;
      negative tumors, which predominate among young African women). A detailed questionnaire is&#xD;
      being administered in hospital and anthropometry measurements are being taken. Additionally,&#xD;
      subjects are being asked to donate blood, saliva, and stool samples for assessment of genetic&#xD;
      and other biologic markers. Similar materials are being collected from population controls.&#xD;
      In addition to providing unique data relevant for improving prevention activities, this study&#xD;
      will build capacity for additional research activities in Ghana.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 19, 2012</start_date>
  <completion_date type="Actual">April 16, 2020</completion_date>
  <primary_completion_date type="Actual">April 25, 2016</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Breast Cancer</measure>
    <time_frame>Within one year of diagnosis</time_frame>
    <description>Pathologically confirmed diagnosis of breast cancer</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Benign breast disease</measure>
    <time_frame>At biopsy</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">4241</enrollment>
  <condition>Breast Neoplasms</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The source of breast cancer cases included the two largest teaching/cancer treatment&#xD;
        hospitals in the country, Korle Bu Teaching Hospital in Accra and Komfo Anoyke Teaching&#xD;
        Hospital in Kumasi, as well as Peace and Love Hospital, a private hospital in Kumasi that&#xD;
        specializes in breast cancer care and diagnoses and treats a large number of breast cancer&#xD;
        patients. Eligibility criteria for study cases included being recommended for a biopsy&#xD;
        given lesions suspicious of malignancy or presenting at a @@@study hospital for treatment&#xD;
        of pathologically documented breast cancers diagnosed within the preceding year.Controls&#xD;
        were selected from women in the catchment area of the hospitals using data from the 2010&#xD;
        Census, matched on age and geographical area to the the cases.@@@@@@&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        -  ELIGIBILITY CRITERIA:&#xD;
&#xD;
        Eligible for inclusion as cases in this study will be women 18-74 years of age who have&#xD;
        been residents of defined catchment areas surrounding the two cities for at least one year&#xD;
        s time and who are either diagnosed at the study hospitals within the past year (KBTH,&#xD;
        KATH, and PLH) or referred there for clinical care. The catchment area in Accra will&#xD;
        consist of 10 districts in Greater Accra (Accra Metropolitan, Adenta, Tema, Ashaiman, Ga&#xD;
        East, Ga West, Ledzokuku-Krowor, Weija (Ga South), Dangbe East, Dangbe West), two in the&#xD;
        Eastern region (Suhum Kraboa Coaltar, Akwapim South) and one in the Central region (Awutu&#xD;
        Senya). In Kumasi, the catchment area will consist of 7 districts surrounding KATH and PLH&#xD;
        (Atwima Kwanwoma, Atwima Nwabiagya, Bosumtwi, Ejisu Juaben, Afigya Kwabre, Kwabre, and&#xD;
        Kumasi Metropolitan).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>74 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Montserrat Garcia-Closas, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Cancer Institute (NCI)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Ghana</name>
      <address>
        <city>Accra</city>
        <country>Ghana</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kwane Nkrumah University of Science and Technology</name>
      <address>
        <city>Kumasi</city>
        <country>Ghana</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ghana</country>
  </location_countries>
  <reference>
    <citation>Huo D, Ikpatt F, Khramtsov A, Dangou JM, Nanda R, Dignam J, Zhang B, Grushko T, Zhang C, Oluwasola O, Malaka D, Malami S, Odetunde A, Adeoye AO, Iyare F, Falusi A, Perou CM, Olopade OI. Population differences in breast cancer: survey in indigenous African women reveals over-representation of triple-negative breast cancer. J Clin Oncol. 2009 Sep 20;27(27):4515-21. doi: 10.1200/JCO.2008.19.6873. Epub 2009 Aug 24.</citation>
    <PMID>19704069</PMID>
  </reference>
  <reference>
    <citation>Akarolo-Anthony SN, Ogundiran TO, Adebamowo CA. Emerging breast cancer epidemic: evidence from Africa. Breast Cancer Res. 2010 Dec 20;12 Suppl 4(Suppl 4):S8. doi: 10.1186/bcr2737. No abstract available.</citation>
    <PMID>21172092</PMID>
  </reference>
  <reference>
    <citation>Walker AR, Adam FI, Walker BF. Breast cancer in black African women: a changing situation. J R Soc Promot Health. 2004 Mar;124(2):81-5. doi: 10.1177/146642400412400212.</citation>
    <PMID>15067980</PMID>
  </reference>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>August 7, 2012</study_first_submitted>
  <study_first_submitted_qc>August 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 9, 2012</study_first_posted>
  <last_update_submitted>April 16, 2020</last_update_submitted>
  <last_update_submitted_qc>April 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Breast Cancer</keyword>
  <keyword>Epidemiology</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast 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/NCT01661023
org study id: 999912174
secondary id: 12-C-N174
nct id: NCT01661023
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Background:

      - Breast cancer is becoming more common in Africa. A higher number of cases appear in women
      under age 35 than in the developed world. However, little is known about the factors that may
      contribute to breast cancer in Africa. Researchers want to collect information from female
      patients in teaching hospitals in Accra and Kumasi, Ghana and to compare this information
      with that obtained from healthy women in the general population. These two hospitals treat
      most breast cancers in Ghana. The data will provide information regarding factors that
      predispose to the development of breast cancer among women in Ghana.

      Objectives:

      - To identify and study breast cancer risk factors in women in Ghana.

      Eligibility:

        -  Women between 18 and 74 years of age who are diagnosed with breast cancer.

        -  Participants will come from teaching hospitals in Accra and Kumasi, Ghana. Women without
           breast cancer will be identified from the 2010 Ghanaian Census for comparison purposes

      Design:

        -  Participants will answer questions about their health and lifestyle.

        -  Height, weight, and waist/hip measurements will be collected.

        -  Blood and saliva samples will be collected.

        -  Participants will be given a collection kit to collect a stool sample.

        -  Treatment will not be provided as part of this study.
Breast cancer is becoming a more common disease in Africa, with a high proportion of cases
      developing among women under age 50. Despite this, there is scant information on predisposing
      factors in African populations. We are proposing a multidisciplinary case-control study at
      three hospitals in Accra and Kumasi that treat the majority of breast cancers in Ghana. We
      have begun this investigation as a pilot endeavor and are seeking approval for continuation
      into a full-scale effort, which over the two years following the pilot will result in a total
      of approximately 2,000 interviewed cases and 2,000 population controls. Tumor tissue samples
      are being sought from cases in order to classify them into subtypes (including triple
      negative tumors, which predominate among young African women). A detailed questionnaire is
      being administered in hospital and anthropometry measurements are being taken. Additionally,
      subjects are being asked to donate blood, saliva, and stool samples for assessment of genetic
      and other biologic markers. Similar materials are being collected from population controls.
      In addition to providing unique data relevant for improving prevention activities, this study
      will build capacity for additional research activities in Ghana.
observational model: Case-Control
time perspective: Retrospective
measure: Breast Cancer
time frame: Within one year of diagnosis
description: Pathologically confirmed diagnosis of breast cancer
measure: Benign breast disease
time frame: At biopsy
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 74 Years
healthy volunteers: No
last name: Montserrat Garcia-Closas, M.D.
role: Principal Investigator
affiliation: National Cancer Institute (NCI)
facility: 
facility: 
country: Ghana
citation: Huo D, Ikpatt F, Khramtsov A, Dangou JM, Nanda R, Dignam J, Zhang B, Grushko T, Zhang C, Oluwasola O, Malaka D, Malami S, Odetunde A, Adeoye AO, Iyare F, Falusi A, Perou CM, Olopade OI. Population differences in breast cancer: survey in indigenous African women reveals over-representation of triple-negative breast cancer. J Clin Oncol. 2009 Sep 20;27(27):4515-21. doi: 10.1200/JCO.2008.19.6873. Epub 2009 Aug 24.
PMID: 19704069
citation: Akarolo-Anthony SN, Ogundiran TO, Adebamowo CA. Emerging breast cancer epidemic: evidence from Africa. Breast Cancer Res. 2010 Dec 20;12 Suppl 4(Suppl 4):S8. doi: 10.1186/bcr2737. No abstract available.
PMID: 21172092
citation: Walker AR, Adam FI, Walker BF. Breast cancer in black African women: a changing situation. J R Soc Promot Health. 2004 Mar;124(2):81-5. doi: 10.1177/146642400412400212.
PMID: 15067980
responsible party type: Sponsor
mesh term: Breast Neoplasms