Long-Term Follow-up Study of Early Stage Breast Cancer Patients Included in GEICAM Studies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 8,000
- 试验地点
- 73
- 主要终点
- Event Free Survival (EvFS) in neoadjuvant studies.
研究概览
简要总结
This is a multicenter, cohorts study to collect information from patients diagnosed with early-stage invasive breast cancer who have been previously included in a neoadjuvant or adjuvant clinical trial of the GEICAM group.
Patients will be included in this study from the moment of completion of the follow-up of the studies of origin and will be followed for approximately 30 years
详细描述
One consequence of the improvement in survival rates of certain tumors such as breast cancer is the increase in the number of patients available for long-term follow-up in randomized controlled clinical trials. This long follow-up allows an additional long-term evaluation of the efficacy, as well as of the sequelae related to the treatments that may occur beyond the time of the primary analysis.
The target population of the study are all patients who were included in neoadjuvant and adjuvant clinical trials of GEICAM performed by the goup since 1998 in the medical oncology units of the participating sites, ensuring a follow-up of patients of approximately 30 years. This will allow to describe the long-term evolution of the patients with invasive breast cancer in early stages.
The information obtained will be very useful to professionals involved in the diagnosis, treatment and monitoring of breast cancer, hospital managers, patients with this condition and society in general. This study provides data of great interest for the estimation of long-term disease requirements.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients included in neoadjuvant and adjuvant clinical trials with GEICAM's participation. If any of these patients had taken part or is participating in another clinical trial, she/he is eligible for this trial and her/his information will also be collected.
- •Patients whose death or contact loss has not been previously collected in the databases of the original studies.
排除标准
- •Patient who were not included in the analyses of the original studies due to non-compliance of the eligibility criteria or the original study informed consent withdrawal.
结局指标
主要结局
Event Free Survival (EvFS) in neoadjuvant studies.
时间窗: Throughout the whole follow up. Up to 30 years from the beginning of the Study approximately.
The EvFS, is defined as the time from the randomization of the patients in the studies of origin, to the date of one of the following events: * Disease progression during neoadjuvant treatment. * Disease relapse (local, regional or distant) after curative surgery. * Second primary tumors * Death due to any cause.
Disease Free Survival (DFS) in adjuvant studies.
时间窗: Throughout the whole follow up. Up to 30 years from the beginning of the Study approximately.
DFS is defined as the time from the date of randomization of patients in the studies of origin, to the date of one of the following events: * Disease relapse (local, regional or distant) after curative surgery. * Second primary tumors * Death due to any cause.
次要结局
- Overall Survival (OS).(Throughout the whole follow up. Up to 30 years from the beginning of the Study approximately.)