An interventional study of iBreast device and Clinical Breast Examination in Breast Cancer, sponsored by Obafemi Awolowo University. Status unknown at 1 site in Nigeria. Open to female participants aged 30 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-11.
Sponsored by Obafemi Awolowo University · Not applicable, Interventional, and Screening
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Among 21 studies in Breast Neoplasms with a site in Nigeria — 6 open to participants now, 8 under way, 1 of them phase 3. Breast Neoplasms · Nigeria.
Among the 21 studies in Breast Neoplasms with a site in Nigeria, this one has the largest planned enrollment of the 18 interventional ones that give a count, is one of 5 that started in 2021, is one of 7 with no phase, and was the 14th registered.
14,832 studies on the registry are indexed under Breast Neoplasms; 3,320 are open to participants now.
Browse Breast Neoplasms studies →6 of the 21 studies in Breast Neoplasms with a site in Nigeria are open now. Recruiting first, the newest first:
University of Chicago · Sites in Nigeria
Ages 18+ · Women only
Northwestern University · Sites in Nigeria
Ages 18+
Memorial Sloan Kettering Cancer Center · Sites in Nigeria, United States
Ages 18+ · Women only
University College Hospital, Ibadan · Sites in Nigeria
Ages 18–70 · Women only
Obafemi Awolowo University Teaching Hospital · Sites in Nigeria
Healthy volunteers
A study can be open while its sites in Nigeria have not opened yet or have stopped. Only those recruiting at a site in Nigeria →
Of the 2,399 Breast Neoplasms studies recruiting now, 1,570 (65%) set no upper age limit and 592 (25%) stop at 75 or younger; 103 take children under 18; 215 take healthy volunteers.
This study: 30 Years to 70 Years · female · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
21 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 6 · Phase 3 4 · Phase 4 1
First in 2000; this study’s year is marked. 5 started in 2021.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 4,100 is above the median of 72 across 10,903 interventional studies indexed under Breast Neoplasms.
Median enrollment 131 across the 18 interventional studies, 800 across the 3 observational. Of the 9 that completed or were terminated, 3 (33%) have results posted.
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None of the 21 has an industry lead sponsor. The 10 most frequent:
Obafemi Awolowo University is the lead sponsor of 16 studies on the registry; none are open to participants now.
Obafemi Awolowo University has 1 study filed under Breast Neoplasms — fewer than ten, so there is no comparison to draw.
4 of the studies in Breast Neoplasms with a site in Nigeria that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05044689Obafemi Awolowo University Teaching HospitalCase Control Study to Identify Modifiable Risk Factors for Colorectal and Breast Cancer in Nigeria | 2026-12-31 |
| NCT04771871University College Hospital, IbadanMicroRNA Profiles in Triple Negative Breast Cancer | 2027-03 |
| NCT04501419Memorial Sloan Kettering Cancer CenterTablet-based Mobile Health Ultrasound for Point-of-care Breast Cancer Diagnosis in Nigeria | 2027-06-30 |
| NCT05561842Memorial Sloan Kettering Cancer CenterTablet-based Mobile Health Ultrasound for Point-of-care Breast Cancer Diagnosis in Nigeria (Mobile Health: Technology and Outcomes in Low and Middle-Income Countries) | 2027-09-21 |
Add all 4 to your calendar (.ics) → With an account.
Among the 21 studies in Breast Neoplasms with a site in Nigeria, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Device: iBreast device · Other: Clinical Breast Examination · Diagnostic Test: Breast ultrasound · Diagnostic Test: Mammography
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.
Also known as: UE Life Sciences Inc.
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
Also known as: CBE
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.
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.
Participation rate
Percentage of women screened of the total number of eligible women in each community.
Time frame: After year 1 of the 2-year study period
Abnormal call rate
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.
Time frame: After year 1 of the 2-year study period
Breast cancer detection rate
Number of histologically diagnosed cases of breast cancer per 1,000 screened populations.
Time frame: After year 1 of the 2-year study period
Stage at presentation
The tumour, node and metastasis (TNM) stage among those with histologically confirmed breast cancer.
Time frame: After year 1 of the 2-year study period
Timeline from presentation to treatment
Time interval between presentation for screening in the community and treatment in the tertiary hospital
Time frame: After year 1 of the 2-year study period
Retention rate
Number of women who return for repeat annual screening of the total initial number of women screened.
Time frame: After year 2 of the 2-year study period
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: The data can be available beginning 12 months after publication of the study results up to to 36 months post publication.
Access criteria: Researchers with approved proposals
No publications or documents are linked to this record.
Started Dec 2021 (actual). Primary completion is estimated for Oct 2023, 22 months after the start.
Of 2,663 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 22 months is below that.
Counting every sponsor, half of 2,773 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Obafemi Awolowo University