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Impact of Intensive Follow-up for Bone Metastasis on Characteristics and Prognosis of Chinese Breast Cancer Patients

2019年4月21日 更新者:Peking University People's Hospital

Impact of Intensive Follow-up for Bone Metastasis on Characteristics and Prognosis of Chinese Breast Cancer Patients: A Multicenter Retrospective Study

The purpose of this study is to retrospectively collect and analyse the characteristics of breast cancer patients with bone metastasis, and compare the impact of intensive follow-up with standard post-operative surveillance on survival of Chinese breast cancer patients.

研究概览

详细说明

Breast cancer is one of the most common malignant tumors in women, and the incidence rate is gradually increasing, accounts for the first place in the incidence of female malignant tumors. Bone metastasis is the most common distant metastatic site for breast cancer, accounting for approximately 70% of all patients with advanced breast cancer. About 26%-50% of breast cancer patients with primary metastases are bone. Autopsy results showed that the overall incidence of breast cancer bone metastasis was about 47%-85%.

Postoperative routine screening for bone metastases in breast cancer patients, whether domestic or foreign, is not recommended in most guidelines. These recommendations were based on two prospective randomized controlled trials in Italy in 1990s, indicated that a bone scan every six months or annually didn't provide a survival benefit to the patient. However, there were researches showing that about 11% of patients with asymptomatic breast cancer have bone metastases, suggesting that early screening might detect more patients with asymptomatic bone metastases. The meta-analysis also pointed out that early screening may prolong the disease-free survival of patients. Besides, the imaging techniques have advance rapidly and remarkably since then. New trials are needed to figure out whether imaging screening of asymptomatic patients should be routinely performed to detect more asymptomatic bone metastases needs further investigation.

研究类型

观察性的

注册 (实际的)

1500

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Beijing
      • Beijing、Beijing、中国、100044
        • Peking University People's Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 70年 (成人、年长者)

接受健康志愿者

不适用

有资格学习的性别

女性

取样方法

概率样本

研究人群

1500 breast cancer patients with bone metastasis diagnosed between 2006 and 2011

描述

Inclusion Criteria:

A. Histologically proven breast cancer confirmed by biopsy or pathological examination of the resected tumor.

B. Histologically confirmed breast cancer patients, fulfilling any of the following:

  1. . Multiple bone metastases indicated by bone scan
  2. . Bone scan positive, and proven by other imaging examinations, including computed tomography (CT), magnetic resonance imaging (MRI) and X-ray.
  3. . Bone scan positive, with clinical symptoms, including bone pain, pathologic fracture, spinal cord compression and so on.
  4. . Bone metastases indicated by PET-CT
  5. . Histologically proven bone metastases

Exclusion Criteria:

A. No bone metastases confirmed by pathological examination B. Bone metastases secondary to other malignant tumor other than breast cancer C. Secondary primary tumor

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:队列
  • 时间观点:追溯

队列和干预

团体/队列
干预/治疗
Bone metastasis screening
The information about bone metastasis screening is retrospectively collected.
Recommendation and results of bone imaging such as bone scan or PET/CT, or bone CT /MR are collected.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Overall survival
大体时间:60 months, and bone scan is repeated every 12 months
defined as the period from randomization to death from any cause, and it is censored at the last follow-up date when the patient is alive
60 months, and bone scan is repeated every 12 months

次要结果测量

结果测量
措施说明
大体时间
disease-free survival
大体时间:60 months, and bone scan is repeated every 12 months
defined as time to disease recurrence (invasive local, regional, or distant metastasis) or death from any cause
60 months, and bone scan is repeated every 12 months
distant metastasis-free survival
大体时间:60 months, and bone scan is repeated every 12 months
defined as time to distant metastasis
60 months, and bone scan is repeated every 12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年3月1日

初级完成 (实际的)

2019年3月31日

研究完成 (实际的)

2019年3月31日

研究注册日期

首次提交

2019年3月8日

首先提交符合 QC 标准的

2019年4月21日

首次发布 (实际的)

2019年4月23日

研究记录更新

最后更新发布 (实际的)

2019年4月23日

上次提交的符合 QC 标准的更新

2019年4月21日

最后验证

2019年4月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Intensive screening / routine screening的临床试验

3
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