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Completed

NCT Number: NCT06056843

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

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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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Carcinoma Carcinoma in Situ Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Skin Diseases Skin and Connective Tissue Diseases

Age range

40 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Malabar Cancer Care Society Kannur

Kannur, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Primary outcomes

  1. Accuracy of non-radiologist portable ultrasound device for triaging women with positive clinical breast examination

    Time frame: 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 outcomes

  1. Agreement between portable ultrasound device and mammography/ultrasound

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

International Agency for Research on Cancer

Other

Collaborators

  • Bhabha Atomic Research Centre
  • Malabar Cancer Care Society Kannur, India

Registry information

Official study title

Evaluation of a Handheld Ultrasound Device to Triage Women With a Positive Clinical Breast Examination by Trained Health Workers and Medical Officers

Acronym: PUD

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 28, 2023
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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