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
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ge Ma, doctor
- Número de teléfono: +8618262632870
- Correo electrónico: ntmage@sina.com
Ubicaciones de estudio
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Jiangsu
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Kunshan, Jiangsu, Porcelana
- Reclutamiento
- Kunshan First People's Hospital
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Contacto:
- Qin Zhou, doctor
- Número de teléfono: +86-18626179180
- Correo electrónico: 4527472@qq.com
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Nanjing, Jiangsu, Porcelana
- Aún no reclutando
- The Fourth Affiliated Hospital of Nanjing Medical University
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Contacto:
- Jing Tao
- Número de teléfono: +86-13813384227
- Correo electrónico: chnn123@163.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Poner en pantalla
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Ultrasound Active Screening Group
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. |
One standardized breast ultrasound examination performed and interpreted by a qualified physician, with further clinical evaluation of abnormal findings as appropriate. |
|
Sin intervención: Routine Health Management Group
Participants receive conventional community health management and annual physical examination according to local routine practice, without study-specific breast ultrasound screening. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Absolute difference in early-stage breast cancer diagnosis rate
Periodo de tiempo: 24 months after enrollment
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The between-group absolute difference in the proportion of pathologically confirmed breast cancer cases diagnosed at stage I or II. |
24 months after enrollment
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Overall breast cancer detection rate
Periodo de tiempo: 24 months
|
The proportion of participants diagnosed with breast cancer in each group during follow-up. |
24 months
|
|
Late-stage breast cancer diagnosis rate
Periodo de tiempo: Up to 24 months after enrollment
|
The proportion of participants diagnosed with stage III or IV breast cancer in each group. |
Up to 24 months after enrollment
|
|
Breast biopsy rate
Periodo de tiempo: Up to 24 months after enrollment
|
The proportion of participants undergoing a breast biopsy in each group during follow-up. |
Up to 24 months after enrollment
|
Colaboradores e Investigadores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- JS-BC-Elder-Screen-2026
- 2024ZD0524000 (Otro número de subvención/financiamiento: Noncommunicable Chronic Diseases-National Science and Technology Major Project)
- 2024ZD0524004 (Otro número de subvención/financiamiento: Noncommunicable Chronic Diseases-National Science and Technology Major Project)
- 2025ZD0545404 (Otro número de subvención/financiamiento: Noncommunicable Chronic Diseases-National Science and Technology Major Project)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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