The PARTNER Study - An International Prospective Observational Study on Pediatric Patients With Very Rare Tumors.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 6,250
- 试验地点
- 1
- 主要终点
- Epidemiology
研究概览
简要总结
The PARTNER study is an international, prospective, observational study of paediatric patients with very rare tumours.
详细描述
There are some very rare tumors (with an annual incidence of less than two per million children) that can affect children and adolescents. These neoplasms include a wide variety of cancers; some are rare at any age, while others are typical of adults but very rare in children. Due to their rarity, studies have so far been scarce, often lacking univocal diagnostic criteria, and more information is needed to improve treatment outcomes.
The aim of this study is to collect epidemiological, clinical, biological, radiological and treatment data on children and adolescents with rare cancers in order to improve our understanding of these tumors and how their clinical and biological characteristics affect treatment outcomes.
Due to the rarity of these malignancies, international collaboration is necessary to collect sufficient data on each tumour type.
While the investigators are not proposing specific treatments, the data collected will inform recommendations for the diagnosis and treatment of patients.
The PARTNER Study is an observational, prospective study. It is sponsored by Padua University Hospital AOUP (Italy), and all European centres collaborating with the EXPeRT group have been invited to participate. It is a non-profit study, meaning it has no commercial purpose, only the aim of improving knowledge and treatment for children with rare cancers. PARTNER activities are supported in different countries by national funds, as well as by the European Commission through the European Reference Network for Paediatric Oncology (ERN PaedCan). Please visit https://paedcan.ern-net.eu/ for more information.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and adolescents (age 0-18 years) with a primary or relapsed Very Rare Tumor diagnosed and/or treated in a participating country/center.
- •Written informed consent from the patient and/or the parent/legal guardian
排除标准
- •Absence of Written informed consent from the patient and/or the parent/legal guardian
结局指标
主要结局
Epidemiology
时间窗: through study completion, an average of 1 year
Evaluate the number of patients (aged 0-18 years) with different Very Rare Tumors in the different countries: observed cases will be compared with expected cases.
Use of International Recommendations
时间窗: through study completion, an average of 1 year
The study aims to measure the number of patients treated for different neoplasms in different countries, and the proportion of those treated in accordance with the International Recommendations.
Survival of children and adolescents (0-18 years) affected by Very Rare Tumors
时间窗: through study completion, an average of 1 year
The study will correlate the clinical characteristics of the tumor (size, site, extension) with the treatment, the risk of recurrence and survival.
次要结局
未报告次要终点
研究者
Gianni Bisogno
Professor of Paediatrics
Azienda Ospedaliera di Padova