Trial Title:
Tablet-based Mobile Health Ultrasound for Point-of-care Breast Cancer Diagnosis in Nigeria (Mobile Health: Technology and Outcomes in Low and Middle-Income Countries)
NCT ID:
NCT05561842
Condition:
Breast Cancer
Breast Cancer Female
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
breast ultrasound
breast cancer
breast biopsy
breast cancer diagnosis
21-325
Memorial Sloan Kettering Cancer Center
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
mHealth US-breast biopsy
Description:
During this study, women will undergo an US-guided breast biopsy by a radiologist instead
of what is typically performed in Nigerian hospitals, which is either a blind biopsy or
surgical excision. US-guided breast biopsy is the standard of care in the United States
of America because the accuracy is better than blind biopsy and equal to surgical
excision.
Arm group label:
Participants with a solid mass on breast ultrasound
Summary:
The purpose of this study is to train Nigerian radiologists to perform ultrasound-guided
breast biopsies. Researchers will use mHealth devices to create a sustainable and
practical way of training radiologists in Nigeria to perform and clinically implement
US-guided breast biopsies into their practice.
Criteria for eligibility:
Study pop:
Participants will be accrued in medical clinics as determined by the local investigators
and local research staff. Informed consent forms approved by each local IRB will be
obtained by research staff from each site.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Age 18 and older female.
- Breast ultrasound demonstrating a solid mass that is suspicious for cancer, which
would typically undergo either a blind biopsy or surgical excision at the Nigerian
hospital where the patient is seeking diagnosis.
Exclusion Criteria:
- Participants unwilling to sign consent.
- Participants under the age of 18.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Elizabeth Sutton, MD
Phone:
646-888-5455
Facility:
Name:
Lagos University Teaching Hospital
Address:
City:
Idi-Araba
Country:
Nigeria
Status:
Recruiting
Contact:
Last name:
Olubukola Omidiji, MD
Phone:
08122167403
Email:
olubukolaomidiji@yahoo.com
Facility:
Name:
Olabisis Onabanjo University Teaching Hospital (Data Collection Only)
Address:
City:
Sagamu
Country:
Nigeria
Status:
Active, not recruiting
Facility:
Name:
Federal Medical Centre Owo (Data Collection Only)
Address:
City:
Owo
Country:
Nigeria
Status:
Recruiting
Contact:
Last name:
Adedeji Egberongbe, MD
Phone:
08034714382
Email:
deji_egbe@yahoo.com
Facility:
Name:
University College Hospital (Data Collection Only)
Address:
City:
Ibadan
Country:
Nigeria
Status:
Recruiting
Contact:
Last name:
Milicent Obajimi, MBBS
Phone:
08034093026
Email:
millieobaj@com.ui.edu.ng
Facility:
Name:
University Of Nigeria Teaching Hospital (UNTH) Ituku-Ozalla Enugu
Address:
City:
Enugu
Country:
Nigeria
Status:
Recruiting
Contact:
Last name:
Nneka Iloanusi, MD
Phone:
08033143023
Email:
nneka.iloanusi@unn.edu.ng
Facility:
Name:
Obafemi Awolowo University Teaching Hospitals Complex (Data Collection Only)
Address:
City:
Ile-Ife
Country:
Nigeria
Status:
Recruiting
Contact:
Last name:
Adeleye Omisore, MD
Phone:
+2348031538004
Email:
omisoreadeleye@yahoo.com
Facility:
Name:
University of Ilorin Teaching Hospitals
Address:
City:
Ilorin
Country:
Nigeria
Status:
Recruiting
Contact:
Last name:
Halimat Akande, MD
Phone:
08035967327
Email:
limadee@yahoo.co.uk
Start date:
September 21, 2022
Completion date:
September 21, 2027
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05561842
http://www.mskcc.org
