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

International Agency for Research on Cancer

Status

Enrolling

Conditions

Breast Cancer

Carcinoma in Situ

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT06056843

IEC 21-04

Details and patient eligibility

About

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.

Full description

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.

Enrollment

150 estimated patients

Sex

Female

Ages

40 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Clinical breast examination positive women with no debilitating illness.
Symptomatic women found to be positive on clinical breast examination by nurses/midwives or medical officers.

Exclusion criteria