Clinical trial · Interventional
Breast Ultrasound Screening in Elderly Women: A Multicenter Cluster Randomized Trial
A Multicenter Cluster Randomized Controlled Trial on the Necessity of Breast Cancer Ultrasound Screening in Elderly Women
NCT07698366CI-TRIAL-00117848recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260929-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Early Detection of Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standardized Breast Ultrasound Screening | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ultrasound Active Screening Group
- description
- 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.
- interventionNames
- Diagnostic Test: Standardized Breast Ultrasound Screening
- type
- NO_INTERVENTION
- label
- Routine Health Management Group
- description
- Participants receive conventional community health management and annual physical examination according to local routine practice, without study-specific breast ultrasound screening.
Primary outcomes (1)
- measure
- Absolute difference in early-stage breast cancer diagnosis rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 65 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Female participants aged 65-80 years. * Local residents living in participating communities for ≥6 months. * Signed informed consent and willingness to participate. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.