Breast CancerPUDNCT06056843
Handheld Ultrasound Device to Triage Women With a Positive Clinical Breast Examination by Trained Non-radiologists
A study testing Triage of clinical breast examination positive women using handheld ultrasound by non-radiologists. in people with Breast Cancer and Carcinoma in Situ, run by International Agency for Research on Cancer at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Carcinoma in Situ
- What is being tested?
- Triage of clinical breast examination positive women using handheld ultrasound by non-radiologists.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIndia
- Study dates
- 9 May 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Women with confirmed diagnosis of breast cancer or those already treated for the disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Handheld Ultrasound Device to Triage Women With a Positive Clinical Breast Examination by Trained Health Workers and Medical Officers
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.
Read the 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.
- Conditions
- Breast Cancer, Carcinoma in Situ
- Being tested
- Triage of clinical breast examination positive women using handheld ultrasound by non-radiologists.
- Keywords
- Breast cancer, Screening, Low- and middle-income countries, Clinical breast examination, Portable ultrasound device, Triage
- Medical subject headings
- Breast Neoplasms, Carcinoma in Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Triage of clinical breast examination positive women using handheld ultrasound by non-radiologists. Receives: Other: Triage of clinical breast examination positive women using handheld ultrasound by non-radiologists. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 1 year
Secondary outcomes (1)
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.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start9 May 2022
- Primary completion30 Jun 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Agency for Research on Cancer
- Sponsor type
- University, hospital or other
- Collaborators
- Malabar Cancer Care Society Kannur, India, Bhabha Atomic Research Centre
- Responsible party
- Principal investigator, Farida Selmouni, International Agency for Research on Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06056843
- Sponsor's protocol ID
- IEC 21-04
- Acronym
- PUD
- Status last verified
- Mar 2026
- First submitted
- 21 Sep 2023
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pai DK, Sarkar DK, Gangadharan H, Muwonge R, Lucas E, Ravindran VC, Basu S, Sajjan M, Selmouni F, Carvalho AL, Gadgil A, Kantharia S, Basu P. Use of Portable Ultrasound by Nonradiologists to Triage Women With Abnormal Clinical Breast Examination Findings: A Prospective Study in India. JCO Glob Oncol. 2026 Oct;12(10):e2600354. doi: 10.1200/GO-26-00354. Epub 2026 Oct 28.
PubMed 42950178
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Handheld Ultrasound Device to Triage Women With a Positive Clinical Breast Examination by Trained Health Workers and Medical Officers
- ClinicalTrials.gov ID
- NCT06056843
- Acronym / sponsor ID
- PUD / IEC 21-04
- Conditions
- Breast Cancer, Carcinoma in Situ
- Keywords
- Breast cancer, Screening, Low- and middle-income countries, Clinical breast examination, Portable ultrasound device, Triage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- International Agency for Research on CancerUniversity, hospital or other
- Collaborators
- Malabar Cancer Care Society Kannur, India, Bhabha Atomic Research Centre
- Study start
- 9 May 2022 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Other: Triage of clinical breast examination positive women using handheld ultrasound by non-radiologists.Triage of clinical breast examination positive women using handheld ultrasound by non-radiologists. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Women with confirmed diagnosis of breast cancer or those already treated for the disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Intervention arm |
Primary outcome
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.
1 secondary outcome
Agreement between portable ultrasound device and mammography/ultrasound
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Derived from this study: PubMed 42950178Pai DK, Sarkar DK, Gangadharan H, Muwonge R, Lucas E, Ravindran VC, Basu S, Sajjan M, Selmouni F, Carvalho AL, Gadgil A, Kantharia S, Basu P. Use of Portable Ultrasound by Nonradiologists to Triage Women With Abnormal Clinical Breast Examination Findings: A Prospective Study in India. JCO Glob Oncol. 2026 Oct;12(10):e2600354. doi: 10.1200/GO-26-00354. Epub 2026 Oct 28.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triage of clinical breast examination positive women using handheld ultrasound by non-radiologists. in people with Breast Cancer and Carcinoma in Situ, run by International Agency for Research on Cancer at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06056843, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.