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

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ClinicalTrials.gov Identifier: NCT06056843
Recruitment Status : Recruiting
First Posted : September 28, 2023
Last Update Posted : October 2, 2023
Sponsor:
Collaborators:
Malabar Cancer Care Society Kannur, India
Bhabha Atomic Research Centre (BARC), India
Information provided by (Responsible Party):
Farida Selmouni, International Agency for Research on Cancer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer Carcinoma in Situ Other: Triage of clinical breast examination positive women using handheld ultrasound by non-radiologists. Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Evaluation of a Handheld Ultrasound Device to Triage Women With a Positive Clinical Breast Examination by Trained Health Workers and Medical Officers
Actual Study Start Date : May 9, 2022
Estimated Primary Completion Date : February 28, 2024
Estimated Study Completion Date : May 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention arm
Triage of clinical breast examination positive women using handheld ultrasound by non-radiologists.
 Other: 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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06056843


Contacts
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Contact: Farida Selmouni, PhD + 33 4 72 73 84 99 SelmouniF@iarc.who.int

Locations
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India
Malabar Cancer Care Society Kannur Recruiting
Kannur, India
Contact: D. Krishnanadha Pai    +91 497 270 5309    cancercarekannur@gmail.com   
Sponsors and Collaborators
International Agency for Research on Cancer
Malabar Cancer Care Society Kannur, India
Bhabha Atomic Research Centre (BARC), India
More Information
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Responsible Party: Farida Selmouni, Scientist, International Agency for Research on Cancer
ClinicalTrials.gov Identifier: NCT06056843    
Other Study ID Numbers: IEC 21-04
First Posted: September 28, 2023    Key Record Dates
Last Update Posted: October 2, 2023
Last Verified: September 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Farida Selmouni, International Agency for Research on Cancer:
Breast cancer
Screening
Low- and middle-income countries
 Clinical breast examination
Portable ultrasound device
Triage
Additional relevant MeSH terms:
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Carcinoma in Situ
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type