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A Multicenter, Open and Observational Real World Study on the Prognosis and Treatment in Young Women With Breast Cancer

2021年7月18日 更新者：Tianjin Medical University Cancer Institute and Hospital

A Observational RWS of YWBC on the Prognosis and Treatment

This is a multicenter, open and observational real world study. The main purpose of this study is to map the genomic variation map of young breast cancer patients in China, and to analyze the relationship between gene mutation and therapeutic effect of young breast cancer patients. The secondary purpose was to analyze the relationship between gene mutation and prognosis of young breast cancer patients.

We expect to enroll 2000 young breast cancer patients (≤35 years old). All patients were detected by targeted next generation sequencing （NGS）(600+ gene panel). Clinical diagnosis, treatment and prognosis information were collected. The Stratification factors mainly include stage, molecular type and treatment method.

研究概览

地位

招聘中

条件

详细说明

The study can only be formally carried out with the written approval of the ethics committee. We regularly submit annual research reports to the ethics committee. We will inform the ethics committee in writing when the study is discontinued and / or completed.

All patients were required to sign informed consent before entering the group. All updated versions of informed consent and written information will be provided to the subjects during the participant's participation.

In the experimental design stage, the statistical principle was used to make reasonable and effective arrangements for the relevant factors. Employ statistical experts to calculate the sample size and data statistics, and participate in the design process. Data collection and follow-up were conducted by specially assigned personnel, professional doctors were assigned to conduct data review regularly, and special data management personnel were provided. They will ensure the authenticity, reliability and security of data throughout the process.

研究类型

观察性的

注册 (预期的)

2000

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

  • 中国
      • Tianjin、中国、300060
        • 招聘中
        • Tianjin Medical University Cancer Institute and 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 35年 (成人)

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

We expect to enroll 2000 young breast cancer patients (18-35 years old). All patients were detected by targeted next generation sequencing （NGS）(600+ gene panel).

Subgroups were stratified according to different stages, treatment methods and pathological types.

The gene mutation characteristics, treatment sensitive genes and prognosis gene spectrum of different groups and subgroups were studied.

描述

Inclusion Criteria:

  1. Histologically confirmed as breast cancer.
  2. The age of diagnosis was 18-35 years old.
  3. ECOG score was 0-2, and the expected survival time was more than 3 months.
  4. No serious complications; no liver, kidney, hematopoiesis dysfunction.
  5. Informed consent, and patients willing to long-term follow-up. -

Exclusion Criteria:

  1. 4 weeks before the start of the study, the use of drugs other than the trial, or participate in another clinical study at the same time, or others with an impact on the results of this study.
  2. Having a clear history of neurological or mental disorders (including epilepsy or dementia).
  3. Patients have uncontrollable complications, including active infection, symptomatic congestive heart failure, unstable angina pectoris, arrhythmia, decompensated diabetes, uncontrollable hypertension or mental disorders.
  4. Pregnant or lactating female patients.
  5. HIV infected patients.
  6. Patients with other tumors.
  7. After comprehensive evaluation, the researchers believe that patients are not suitable for this study.

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

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
PFS
大体时间：5 years
The time from the first medication at the beginning of treatment to the first disease progression or death from any cause
5 years

次要结果测量

结果测量
措施说明
大体时间
OS
大体时间：5 years
time from randomization to death from any cause
5 years
ORR
大体时间：5 years
After treatment, the percentage of patients whose tumor volume reduced to a predetermined value and could maintain the minimum time limit was evaluated, including complete remission (CR) + partial remission (PR)
5 years

其他结果措施

结果测量
措施说明
大体时间
AEs
大体时间：5 years
It refers to any adverse medical event during the clinical study. It is not necessarily a causal relationship with treatment.
5 years

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。

赞助

Tianjin Medical University Cancer Institute and Hospital

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)

2020年4月1日

初级完成 (预期的)

2023年3月31日

研究完成 (预期的)

2025年3月31日

研究注册日期

首次提交

2021年2月26日

首先提交符合 QC 标准的

2021年7月18日

首次发布 (实际的)

2021年7月21日

研究记录更新

最后更新发布 (实际的)

2021年7月21日

上次提交的符合 QC 标准的更新

2021年7月18日

最后验证

2021年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • YWBC-001

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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.

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