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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Ge Ma, doctor
- 전화번호: +8618262632870
- 이메일: ntmage@sina.com
연구 장소
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Jiangsu
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Kunshan, Jiangsu, 중국
- 모병
- Kunshan First People's Hospital
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연락하다:
- Qin Zhou, doctor
- 전화번호: +86-18626179180
- 이메일: 4527472@qq.com
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Nanjing, Jiangsu, 중국
- 아직 모집하지 않음
- The Fourth Affiliated Hospital of Nanjing Medical University
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연락하다:
- Jing Tao
- 전화번호: +86-13813384227
- 이메일: chnn123@163.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 상영
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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. |
|
간섭 없음: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Absolute difference in early-stage breast cancer diagnosis rate
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Overall breast cancer detection rate
기간: 24 months
|
The proportion of participants diagnosed with breast cancer in each group during follow-up. |
24 months
|
|
Late-stage breast cancer diagnosis rate
기간: 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
기간: 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
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- JS-BC-Elder-Screen-2026
- 2024ZD0524000 (기타 보조금/기금 번호: Noncommunicable Chronic Diseases-National Science and Technology Major Project)
- 2024ZD0524004 (기타 보조금/기금 번호: Noncommunicable Chronic Diseases-National Science and Technology Major Project)
- 2025ZD0545404 (기타 보조금/기금 번호: Noncommunicable Chronic Diseases-National Science and Technology Major Project)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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