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The Ghana Breast Health Study

16. april 2020 opdateret af: National Cancer Institute (NCI)

A Multidisciplinary Study of Breast Cancer in Ghana

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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

4241

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Ghana
      • Accra, Ghana
        • University of Ghana
      • Kumasi, Ghana
        • Kwane Nkrumah University of Science and Technology

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 74 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

The source of breast cancer cases included the two largest teaching/cancer treatment hospitals in the country, Korle Bu Teaching Hospital in Accra and Komfo Anoyke Teaching Hospital in Kumasi, as well as Peace and Love Hospital, a private hospital in Kumasi that specializes in breast cancer care and diagnoses and treats a large number of breast cancer patients. Eligibility criteria for study cases included being recommended for a biopsy given lesions suspicious of malignancy or presenting at a @@@study hospital for treatment of pathologically documented breast cancers diagnosed within the preceding year.Controls were selected from women in the catchment area of the hospitals using data from the 2010 Census, matched on age and geographical area to the the cases.@@@@@@

Beskrivelse

  • ELIGIBILITY CRITERIA:

Eligible for inclusion as cases in this study will be women 18-74 years of age who have been residents of defined catchment areas surrounding the two cities for at least one year s time and who are either diagnosed at the study hospitals within the past year (KBTH, KATH, and PLH) or referred there for clinical care. The catchment area in Accra will consist of 10 districts in Greater Accra (Accra Metropolitan, Adenta, Tema, Ashaiman, Ga East, Ga West, Ledzokuku-Krowor, Weija (Ga South), Dangbe East, Dangbe West), two in the Eastern region (Suhum Kraboa Coaltar, Akwapim South) and one in the Central region (Awutu Senya). In Kumasi, the catchment area will consist of 7 districts surrounding KATH and PLH (Atwima Kwanwoma, Atwima Nwabiagya, Bosumtwi, Ejisu Juaben, Afigya Kwabre, Kwabre, and Kumasi Metropolitan).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Breast Cancer
Tidsramme: Within one year of diagnosis
Pathologically confirmed diagnosis of breast cancer
Within one year of diagnosis

Sekundære resultatmål

Resultatmål
Tidsramme
Benign breast disease
Tidsramme: At biopsy
At biopsy

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Cancer Institute (NCI)

Efterforskere

  • Ledende efterforsker: Montserrat Garcia-Closas, M.D., National Cancer Institute (NCI)

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

19. juli 2012

Primær færdiggørelse (Faktiske)

25. april 2016

Studieafslutning (Faktiske)

16. april 2020

Datoer for studieregistrering

Først indsendt

7. august 2012

Først indsendt, der opfyldte QC-kriterier

7. august 2012

Først opslået (Skøn)

9. august 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. april 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. april 2020

Sidst verificeret

1. april 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 999912174
  • 12-C-N174

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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