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

NCT06056843 | Unknown

• 1 other identifier: IEC 21-04
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Carcinoma in Situ

Keywords

Breast cancer; Screening; Low- and middle-income countries; Clinical breast examination; Portable ultrasound device; Triage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Agreement between portable ultrasound device and mammography/ultrasound

  Through study completion, an average of 1 year

Study Arms (1)

Intervention arm

EXPERIMENTAL

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.

Interventions

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.

Intervention arm

Eligibility Criteria

• Age: 40 Years - 75 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Women with confirmed diagnosis of breast cancer or those already treated for the disease.

Sponsors & Collaborators

• International Agency for Research on Cancer: lead
• Malabar Cancer Care Society Kannur, India: collaborator
• Bhabha Atomic Research Centre (BARC), India: collaborator

Study Sites (1)

Malabar Cancer Care Society Kannur

Kannur, India

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma in Situ

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Central Study Contacts

Farida Selmouni, PhD

CONTACT

+ 33 4 72 73 84 99; SelmouniF@iarc.who.int

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientist

Model Details: 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.

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: September 28, 2023
• Study Start: May 9, 2022
• Primary Completion: February 28, 2024
• Study Completion: May 31, 2024
• Last Updated: October 2, 2023

Record last verified: 2023-09

Locations

IN (1)