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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Ge Ma, doctor
- Telefonnummer: +8618262632870
- E-post: ntmage@sina.com
Studieorter
-
-
Jiangsu
-
Kunshan, Jiangsu, Kina
- Rekrytering
- Kunshan First People's Hospital
-
Kontakt:
- Qin Zhou, doctor
- Telefonnummer: +86-18626179180
- E-post: 4527472@qq.com
-
Nanjing, Jiangsu, Kina
- Har inte rekryterat ännu
- The Fourth Affiliated Hospital of Nanjing Medical University
-
Kontakt:
- Jing Tao
- Telefonnummer: +86-13813384227
- E-post: chnn123@163.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Undersökning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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. |
|
Inget ingripande: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Absolute difference in early-stage breast cancer diagnosis rate
Tidsram: 24 months after enrollment
|
The between-group absolute difference in the proportion of pathologically confirmed breast cancer cases diagnosed at stage I or II. |
24 months after enrollment
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Overall breast cancer detection rate
Tidsram: 24 months
|
The proportion of participants diagnosed with breast cancer in each group during follow-up. |
24 months
|
|
Late-stage breast cancer diagnosis rate
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- JS-BC-Elder-Screen-2026
- 2024ZD0524000 (Annat bidrag/finansieringsnummer: Noncommunicable Chronic Diseases-National Science and Technology Major Project)
- 2024ZD0524004 (Annat bidrag/finansieringsnummer: Noncommunicable Chronic Diseases-National Science and Technology Major Project)
- 2025ZD0545404 (Annat bidrag/finansieringsnummer: Noncommunicable Chronic Diseases-National Science and Technology Major Project)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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.
Läkemedels- och apparatinformation, studiedokument
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