Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Carcinoma

Carcinoma in Situ

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Triage of clinical breast examination positive women using handheld ultrasound by non-radiologists.

Women screened for breast cancer by clinical breast examination (CBE). Those with positive CBE will be triaged by portable ultrasound device by non-radiologists. All recruited women will receive a diagnostic mammography and, if necessary, an ultrasound performed by a radiologist. The radiologist will be blinded to the portable ultrasound device findings. Those with suspected lesions either on mammography or ultrasound will have fine needle aspiration cytology (FNAC) or core biopsy. The women with confirmed diagnosis of breast cancer will be staged and appropriately treated as per the policy of the hospital.

Farida Selmouni, PhD

D. Krishnanadha Pai

Cross sectional study to evaluate estimate accuracy of portable ultrasound device in correctly differentiating the benign breast lesions from the malignant ones in the women referred with a positive Clinical breast examination (CBE) screening test.

More than two million new cases of breast cancer occur each year worldwide. Implementing mammography screening is complex and resource-intensive, making it impractical in resource-limited settings. Clinical breast examination (CBE) has been recommended as an alternative screening option for low- and middle-income countries. Several studies have shown a significant shift towards earlier stage tumours detected by CBE. However, the high false-positive rate and low positive predictive value of CBE expose women to unnecessary and costly further diagnostic procedures, as well as the negative psychological consequences. There is an urgent need for a more accurate, cost-effective and reliable triage technology that can be performed by any healthcare provider.

This is a single-arm study in which women with a positive clinical breast examination will be triaged using a portable ultrasound device by non-radiologists. The gold standard is mammography, ultrasound and histology if needed.

Handheld Ultrasound Device to Triage Women With a Positive Clinical Breast Examination by Trained Non-radiologists

Evaluation of a Handheld Ultrasound Device to Triage Women With a Positive Clinical Breast Examination by Trained Health Workers and Medical Officers

Sensitivity, specificity and positive and negative predictive values of portable ultrasound device to detect breast cancer and carcinoma in situ with repeat clinical breast examination, mammography/ultrasound and/or cytology/core biopsy as the gold standard test.

Agreement between portable ultrasound device and mammography/ultrasound by a radiologist in differentiating malignant and benign solid breast lesions.

Malabar Cancer Care Society Kannur, India

Bhabha Atomic Research Centre (BARC), India

International Agency for Research on Cancer

Scientist

Breast Diseases

Skin Diseases

Two districts in Ife East Local County with an estimated screening population of 4,500 will be randomly selected to serve as the control community. The control arm will not receive iBE screening and clinical breast examinations by the community health nurses and nor get navigated to have ultrasound, mammography, biopsy and referral for treatment to the tertiary hospital if indicated within their community. All women for screening and diagnostic workup in the control community will be directed to the tertiary hospital to receive breast care.

Three districts in Ife North Local County with an estimated screening population (women 40-70 years) of 5,800 will be randomly selected to serve as the intervention community. Women in the intervention community will receive iBreast and clinical breast examinations by the community health nurses and get navigated to have ultrasound, mammography, biopsy and referral for treatment to the tertiary hospital if indicated within their community.

The iBreast (iBE) device is an automated, battery powered, portable device designed to be used by community health nurses as a screening and triage tool. The iBE is designed to be used by a community health worker or lay person after appropriate training. In resource-limited settings, it potentially provides an easily accessible, low-cost method to assess the breast for findings that warrant further evaluation.

iBreast device

The standard clinical breast examination (CBE) will be performed by the community health nurses in the selected primary health care centers where patients will present for screening or diagnostic workup in the intervention community

Clinical Breast Examination

Women in the intervention community who have positive iBE and/or CBE findings will be navigated by the community health nurses to have ultrasound with or without ultrasound-guided breast biopsy if indicated by the radiologist using portable ultrasound tablets that will be brought to the intervention community.

Breast ultrasound

Women in the intervention community who have positive iBE and/or CBE findings will be navigated by the community health nurses to have mammography done using a mobile mammography van that will be brought to the intervention community.

Mammography

Adeleye D Omisore, MBBS, M.Sc, FWACS, FMCR

The goal of this study is to establish a novel community-based breast cancer program to address delayed presentation and lack of access to diagnostic and treatment facilities in South-West Nigeria. It is aimed at evaluating the impact of a novel breast cancer early detection program using triple mobile assessment (innovative handheld iBreast Exam \[iBE\] device, mobile ultrasound, and mobile mammography) and patient navigation program in a Nigerian community.

This study aims to provide screening to asymptomatic women 40-70 years and to provide diagnostic evaluation to women 30-70 years presenting with breast symptoms in a community in South-West Nigeria.

The project will use a cluster randomized design with 1 community serving as the intervention arm and another community serving as the control arm. Both communities will receive breast cancer awareness and education but only the intervention community will receive screening, mobile imaging and navigation. Screening with targeted clinical history, Clinical Breast Exam (CBE), and iBE will be performed by trained Community Health Nurses in the intervention community. Women with positive CBE or iBE findings will undergo breast imaging with mobile mammography and portable ultrasound, as well as biopsy when indicated by the Radiologist who visits the community once a month, and receive navigation by the nurses to the point of care. The control population will receive breast cancer awareness without an organized screening, imaging or navigation program. Women presenting to the Primary Health Care Centers in the control community will be referred to the Teaching Hospital as per current standard of care. Record of all breast cancer cases seen in the 2 communities during the study period will be obtained.

The study will be carried out in 2 local counties (Local Government Areas) in Osun State, South-West, Nigeria, Ife North Local County and Ife East Local County. Three districts in Ife North Local County with an estimated screening population (women 40-70 years) of 5,800 will be randomly selected to serve as the intervention community, while 2 districts in Ife East Local County with an estimated screening population of 4,500 will be randomly selected to serve as the control community. Both communities will receive awareness and education, but only the intervention community will receive screening and navigation.

The study is addressing breast cancer screening and treatment in women

Improving Access to Breast Cancer Screening and Treatment in Nigeria: The Triple Mobile Assessment and Patient Navigation Model

The study protocol, statistical analysis plan, and informed consent form will be made available on clinicaltrials.gov if and when required. With study data being uploaded to redcap hosted by the sponsor organization (Obafemi Awolowo University), de-identified individual participant data can be made available under the terms of a data use agreement 12 moths after publication of study results.

Percentage of women screened of the total number of eligible women in each community.

Number of women with abnormalities detected on iBE and/or CBE requiring further evaluation either by imaging or biopsy out of the total number of women screened.

Number of histologically diagnosed cases of breast cancer per 1,000 screened populations.

The tumour, node and metastasis (TNM) stage among those with histologically confirmed breast cancer.

Time interval between presentation for screening in the community and treatment in the tertiary hospital

Number of women who return for repeat annual screening of the total initial number of women screened.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Handheld Ultrasound Device to Triage Women With a Positive Clinical Breast Examination by Trained Non-radiologists	NCT06056843	Breast Cancer Carcinoma in Si...	Triage of clini...	40 Years - 75 Years	International Agency for Research on Cancer
Handheld Ultrasound Device to Triage Women With a Positive Clinical Breast Examination by Trained Non-radiologists	NCT06056843	Breast Cancer Carcinoma in Si...	Triage of clini...	40 Years - 75 Years	International Agency for Research on Cancer
Improving Access to Breast Cancer Screening and Treatment in Nigeria: The Triple Mobile Assessment and Patient Navigation Model	NCT05321823	Breast Cancer	iBreast device Clinical Breast... Breast ultrasou... Mammography	30 Years - 70 Years	Obafemi Awolowo University

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