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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Ge Ma, doctor
- Telefonnummer: +8618262632870
- E-mail: ntmage@sina.com
Studiesteder
-
-
Jiangsu
-
Kunshan, Jiangsu, Kina
- Rekruttering
- Kunshan First People's Hospital
-
Kontakt:
- Qin Zhou, doctor
- Telefonnummer: +86-18626179180
- E-mail: 4527472@qq.com
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Nanjing, Jiangsu, Kina
- Ikke rekrutterer endnu
- The Fourth Affiliated Hospital of Nanjing Medical University
-
Kontakt:
- Jing Tao
- Telefonnummer: +86-13813384227
- E-mail: chnn123@163.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Screening
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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. |
|
Ingen indgriben: 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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Absolute difference in early-stage breast cancer diagnosis rate
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall breast cancer detection rate
Tidsramme: 24 months
|
The proportion of participants diagnosed with breast cancer in each group during follow-up. |
24 months
|
|
Late-stage breast cancer diagnosis rate
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- JS-BC-Elder-Screen-2026
- 2024ZD0524000 (Andet bevillings-/finansieringsnummer: Noncommunicable Chronic Diseases-National Science and Technology Major Project)
- 2024ZD0524004 (Andet bevillings-/finansieringsnummer: Noncommunicable Chronic Diseases-National Science and Technology Major Project)
- 2025ZD0545404 (Andet bevillings-/finansieringsnummer: Noncommunicable Chronic Diseases-National Science and Technology Major Project)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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.
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