Breast NeoplasmsNCT07698366
Breast Ultrasound Screening in Elderly Women: A Multicenter Cluster Randomized Trial
A study testing Standardized Breast Ultrasound Screening in people with Breast Neoplasms and Early Detection of Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 2 sites in China.
Trial summary
This multicenter, cluster randomized trial will evaluate whether community-based breast ultrasound screening improves the early detection of breast cancer in women aged 65 to 80 years, compared with routine health management. Read more about this study
- Who is it for?
- Ages 65 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Neoplasms, Early Detection of Cancer
- What is being tested?
- Standardized Breast Ultrasound Screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80,000 participants
- Where
- 2 sitesChina
- Study dates
- 20 Sep 2026to 31 Dec 2029
- Phase
- Interventional
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 65 to 80 years
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Female participants aged 65-80 years.
- Local residents living in participating communities for ≥6 months.
- Signed informed consent and willingness to participate.
Who cannot join
- History of breast cancer or previous breast cancer treatment.
- Breast cancer screening within the past 2 years.
- Severe comorbid conditions that may affect study participation or follow-up.
- Acute breast disease or conditions requiring immediate treatment.
- Unable to cooperate with screening procedures due to physical or cognitive limitations.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Kunshan First People's Hospital
Kunshan, Jiangsu
Qin Zhou, doctor, +86-18626179180, 4527472@qq.com
- Not yet recruiting
The Fourth Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu
Jing Tao, +86-13813384227, chnn123@163.com
About this study
Official title: A Multicenter Cluster Randomized Controlled Trial on the Necessity of Breast Cancer Ultrasound Screening in Elderly Women
This multicenter, cluster randomized trial will evaluate whether community-based breast ultrasound screening improves the early detection of breast cancer in women aged 65 to 80 years, compared with routine health management. Approximately 80,000 women in Jiangsu Province, China, will be enrolled and followed for breast cancer outcomes.
Read the detailed description
This is a multicenter, open-label, cluster randomized controlled trial in Jiangsu Province, China. Approximately 80,000 women aged 65 to 80 years will be enrolled. Participating community health service stations will be assigned to either active breast ultrasound screening or routine health management. Women in the screening group will receive a standardized breast ultrasound examination, while those in the control group will receive no additional study-specific breast screening. The primary outcome is the difference between groups in the proportion of diagnosed breast cancers that are stage I or II during 24 months of follow-up. The study will also assess other screening-related and implementation outcomes.
- Conditions
- Breast Neoplasms, Early Detection of Cancer
- Being tested
- Standardized Breast Ultrasound Screening
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Breast Ultrasound ScreeningDiagnostic test
One standardized breast ultrasound examination performed and interpreted by a qualified physician, with further clinical evaluation of abnormal findings as appropriate.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound Active Screening Group | Experimental | Participants assigned to this group through their community health service station receive one standardized breast ultrasound examination performed by a qualified physician. Abnormal findings are managed according to routine clinical practice. Receives: Diagnostic Test: Standardized Breast Ultrasound Screening |
| Routine Health Management Group | No intervention | Participants receive conventional community health management and annual physical examination according to local routine practice, without study-specific breast ultrasound screening. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute difference in early-stage breast cancer diagnosis rate
The between-group absolute difference in the proportion of pathologically confirmed breast cancer cases diagnosed at stage I or II.
Measured: 24 months after enrollment
Secondary outcomes (3)
Overall breast cancer detection rate
The proportion of participants diagnosed with breast cancer in each group during follow-up.
Measured: 24 months
Late-stage breast cancer diagnosis rate
The proportion of participants diagnosed with stage III or IV breast cancer in each group.
Measured: Up to 24 months after enrollment
Breast biopsy rate
The proportion of participants undergoing a breast biopsy in each group during follow-up.
Measured: Up to 24 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start20 Sep 2026
- Primary completion20 Sep 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07698366
- Sponsor's protocol ID
- JS-BC-Elder-Screen-2026
- Other IDs
- 2024ZD0524000, 2024ZD0524004, 2025ZD0545404
- Status last verified
- Sep 2026
- First submitted
- 8 Jul 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because there is currently no approved data sharing policy for this multicenter study. De-identified participant data will be managed in accordance with institutional regulations and applicable ethical and legal requirements.