Early breast cancer detection
for every woman in Cameroon
A portable AI-powered screening device evaluated across 20 hospital sites in all 10 regions of Cameroon. Free for 2,840 women aged 25 and above.
About the study
A rigorous multicenter evaluation of AI-powered breast cancer screening across all 10 regions of Cameroon
The device
IntelliBra is a connected brassiere integrating miniaturized ultrasound sensors and infrared thermography, analyzed by an embedded AI algorithm in real time. It connects to a mobile application that transmits results to the Cameroon National Breast Cancer Registry (CNBCR).
The comparison
Results are compared against the standard reference examination: breast ultrasound for women under 40 and digital mammography for women aged 40 and above. In cases of suspected abnormality, biopsy serves as the definitive reference standard.
Primary outcome
The primary aim is to measure the sensitivity and specificity of IntelliBra versus the reference standard. Secondary outcomes include PPV, NPV, AUC, patient acceptability, ease of use, and early detection rate.
Data and privacy
All participant data is anonymized and stored in the CNBCR. No national identity number is collected. Data is accessible only to authorized researchers and shared upon formal request with ethical approval.
Study timeline
A phased approach to rigorous clinical validation
Preparation
Formation of research team, ethics submission to CNERSH, regulatory filing with Cameroon health authorities, equipment deployment across 20 sites, staff training. Self-financed by ANORA S.A.S.
Pilot
Initial testing of study procedures and protocols before full-scale deployment. Feasibility and protocol validation. Results used to confirm readiness for expansion.
Extension
Validation of Phase I results on a broader sample. Comparative analysis between phases. Funding secured through fundraising based on Phase I outcomes.
Full deployment
Complete multicenter study across all 10 regions. Final statistical analysis including sensitivity, specificity, AUC, PPV, NPV, and acceptability metrics. Submission for peer-reviewed publication.
Results publication
Summary results published in the PACTR registry and submitted to peer-reviewed journals per WHO requirements. Data made available via the CNBCR platform for qualified secondary research.
Who can participate
All examinations, consultations, and follow-up visits are free of charge. Participation may be withdrawn at any time without consequence.
Inclusion criteria
- Women aged 25 years or older
- Residing in areas covered by participating study centers
- Voluntarily agreed to participate after receiving full informed consent
- Available for follow-up examinations at 6 and 12 months if required
- Women with or without prior history of breast disease or risk factors
Exclusion criteria
- Confirmed pregnancy at the time of enrollment
- History of major breast surgery that altered breast morphology
- Serious unstabilized medical condition preventing safe participation
- Currently undergoing active treatment for breast cancer
- Invasive breast procedure within 6 months prior to enrollment
- Refusal to sign the informed consent form
All examinations, consultations, biopsy procedures, and follow-up visits are provided free of charge. No financial compensation is offered. Participation is entirely voluntary and may be withdrawn at any time.
Recruiting centers
Reference hospital sites across all 10 administrative regions of Cameroon
Adamawa
1Centre Hospitalier Régional de Ngaoundéré
Ngaoundéré
Centre
3Hôpital Gynéco-Obstétrique et Pédiatrique de Yaoundé
Yaoundé
Centre Hospitalier Universitaire de Yaoundé
Yaoundé
Hôpital Central de Yaoundé
Yaoundé
East
1Centre Hospitalier Régional de Bertoua
Bertoua
Far North
2Hôpital Régional de Maroua
Maroua
Hôpital Régional de Yagoua
Yagoua
Littoral
4Hôpital Régional de Nkongsamba
Nkongsamba
Hôpital Régional d'Edéa
Edéa
Hôpital Gynéco-Obstétrique de Douala
Douala
Hôpital Laquintinie de Douala
Douala
North
2Hôpital Régional de Garoua
Garoua
Hôpital de Référence de Garoua
Garoua
North West
1Hôpital Régional de Bamenda
Bamenda
West
2Centre Hospitalier Régional de Bafoussam
Bafoussam
Hôpital de District de Foumban
Foumban
South
2Centre Hospitalier Régional d'Ebolowa
Ebolowa
Hôpital de Référence de Sangmélima
Sangmélima
South West
2Hôpital Régional de Buea
Buea
Hôpital Régional de Limbé
Limbé
Research team
Led by clinicians and researchers with deep expertise in cancer care and AI-powered diagnostics
Prof. Blaise Nkegoum
Principal Investigator
Permanent Secretary, National Cancer Control Programme, Cameroon
Dr. Michel Auguste Mouelle
Co-Investigator
UICC Technical Fellow 2024
ANORA S.A.S
Primary Sponsor
Cameroonian startup, Yaoundé, Cameroon
ABCRF
Secondary Sponsor
Anora Breast Cancer Research Foundation, Yaoundé, Cameroon
Documents
Study documents available for download
Ethics Clearance Certificate (CNERSH)
All
Statistical Analysis Plan
Researchers
Summary Results
All
Registry & regulatory status
Registration and ethics oversight information
- PACTR Number
- Pending, registration in progress
- ClinicalTrials.gov NCT
- Pending
- Protocol Number
- ANORA-INTBRA-CT-2025-V2.2
- Ethics Committee
- CNERSH, Comité National d'Éthique de la Recherche pour la Santé Humaine
- Ethics Status
- Submission pending, number to be inserted upon issuance
- Regulatory Filing (DROS)
- Underway with Cameroon Ministry of Public Health
- IPD Sharing
- Yes, anonymized data via CNBCR platform, 12 months post-completion
PACTR and ClinicalTrials.gov numbers will link to live registry records once issued.
Contact
Reach the research team, ethics committee, or submit a data access request
Principal Investigator
- Name
- Prof. Blaise NKegoum
- Title
- Principal Investigator
- Address
- Yaoundé, Emana Rue 9562, Cameroon
- Phone
- +237 656 170 749 / +237 670 629 094
Ethics Committee
- Name
- CNERSH, Comité National d'Éthique de la Recherche pour la Santé Humaine
- Address
- Lieu-dit Hygiène Mobile, Yaoundé, Cameroon
- Phone
- +237 243 674 339 / +237 690 006 781
- setcominae@gmail.com
IntelliBra Clinical Trial · ANORA S.A.S / ABCRF · Yaoundé, Cameroon · 2025
Free screening · No compensation · Voluntary participation
This clinical trial is registered with the Pan African Clinical Trials Registry (PACTR) and conducted under the ethical oversight of CNERSH. All participant data is handled in accordance with applicable national and international data protection standards.