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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Ge Ma, doctor
- Telefonnummer: +8618262632870
- E-Mail: ntmage@sina.com
Studienorte
-
-
Jiangsu
-
Kunshan, Jiangsu, China
- Rekrutierung
- Kunshan First People's Hospital
-
Kontakt:
- Qin Zhou, doctor
- Telefonnummer: +86-18626179180
- E-Mail: 4527472@qq.com
-
Nanjing, Jiangsu, China
- Noch keine Rekrutierung
- The Fourth Affiliated Hospital of Nanjing Medical University
-
Kontakt:
- Jing Tao
- Telefonnummer: +86-13813384227
- E-Mail: chnn123@163.com
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Screening
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
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. |
|
Kein Eingriff: 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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Absolute difference in early-stage breast cancer diagnosis rate
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Overall breast cancer detection rate
Zeitfenster: 24 months
|
The proportion of participants diagnosed with breast cancer in each group during follow-up. |
24 months
|
|
Late-stage breast cancer diagnosis rate
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- JS-BC-Elder-Screen-2026
- 2024ZD0524000 (Andere Zuschuss-/Finanzierungsnummer: Noncommunicable Chronic Diseases-National Science and Technology Major Project)
- 2024ZD0524004 (Andere Zuschuss-/Finanzierungsnummer: Noncommunicable Chronic Diseases-National Science and Technology Major Project)
- 2025ZD0545404 (Andere Zuschuss-/Finanzierungsnummer: Noncommunicable Chronic Diseases-National Science and Technology Major Project)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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