Breast Cancer, Carcinoma in Situ
Conditions
Keywords
Breast cancer, Screening, Low- and middle-income countries, Clinical breast examination, Portable ultrasound device, Triage
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.
Interventions
OTHERTriage 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.
Sponsors
International Agency for Research on Cancer
Malabar Cancer Care Society Kannur, India
Bhabha Atomic Research Centre (BARC), India
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
India
Outcome results
None listed