Breast Cancer Clinical Trial
— PUDOfficial title:
Evaluation of a Handheld Ultrasound Device to Triage Women With a Positive Clinical Breast Examination by Trained Health Workers and Medical Officers
NCT number | NCT06056843 |
Other study ID # | IEC 21-04 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 9, 2022 |
Est. completion date | May 31, 2024 |
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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | May 31, 2024 |
Est. primary completion date | February 28, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 40 Years to 75 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
India | Malabar Cancer Care Society Kannur | Kannur |
Lead Sponsor | Collaborator |
---|---|
International Agency for Research on Cancer | Bhabha Atomic Research Centre (BARC), India, Malabar Cancer Care Society Kannur, India |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Accuracy of non-radiologist portable ultrasound device for triaging women with positive clinical breast examination | 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. | Through study completion, an average of 1 year | |
Secondary | Agreement between portable ultrasound device and mammography/ultrasound | Agreement between portable ultrasound device and mammography/ultrasound by a radiologist in differentiating malignant and benign solid breast lesions. | Through study completion, an average of 1 year |
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