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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-09

Study Completion Date

2024-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Cancer Carcinoma in Situ

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a single-arm study in which women with a positive clinical breast examination will be triaged using a portable ultrasound device by non-radiologists. The gold standard is mammography, ultrasound and histology if needed.

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Intervention arm

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

Group Type EXPERIMENTAL

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

Intervention Type OTHER

Women screened for breast cancer by clinical breast examination (CBE). Those with positive CBE will be triaged by portable ultrasound device by non-radiologists. All recruited women will receive a diagnostic mammography and, if necessary, an ultrasound performed by a radiologist. The radiologist will be blinded to the portable ultrasound device findings. Those with suspected lesions either on mammography or ultrasound will have fine needle aspiration cytology (FNAC) or core biopsy. The women with confirmed diagnosis of breast cancer will be staged and appropriately treated as per the policy of the hospital.

Interventions

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

Women screened for breast cancer by clinical breast examination (CBE). Those with positive CBE will be triaged by portable ultrasound device by non-radiologists. All recruited women will receive a diagnostic mammography and, if necessary, an ultrasound performed by a radiologist. The radiologist will be blinded to the portable ultrasound device findings. Those with suspected lesions either on mammography or ultrasound will have fine needle aspiration cytology (FNAC) or core biopsy. The women with confirmed diagnosis of breast cancer will be staged and appropriately treated as per the policy of the hospital.

Intervention Type OTHER

Eligibility Criteria

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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.