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

Not Applicable

Recruiting

• Conditions: Carcinoma in Situ; Breast Cancer
• Interventions: Other: Triage of clinical breast examination positive women using handheld ultrasound by non-radiologists.

• Registration Number: NCT06056843
• Lead Sponsor: International Agency for Research on Cancer

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2022-05-09
• Status Verified: 2023-09
• Study First Submitted: 2023-09-21
• Study First Submitted QC: 2023-09-21
• Study First Posted: 2023-09-28
• Last Update Submitted: 2023-09-28
• Last Update Posted: 2023-10-02
• Primary Completion: 2024-02-28
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 150

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

• Women with confirmed diagnosis of breast cancer or those already treated for the disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention arm	Triage of clinical breast examination positive women using handheld ultrasound by non-radiologists.	Triage of clinical breast examination positive women using handheld ultrasound by non-radiologists.

Primary Outcome Measures

Name	Time	Method
Accuracy of non-radiologist portable ultrasound device for triaging women with positive clinical breast examination	Through study completion, an average of 1 year	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.

Secondary Outcome Measures

Name	Time	Method
Agreement between portable ultrasound device and mammography/ultrasound	Through study completion, an average of 1 year	Agreement between portable ultrasound device and mammography/ultrasound by a radiologist in differentiating malignant and benign solid breast lesions.

Trial Locations

Locations (1)

Malabar Cancer Care Society Kannur; 🇮🇳 Kannur, India