A Prospective Registry Study on Biological Disease Profile, Intervention Type and Clinical Outcome in Adolescent and Adult Patients With Soft-tissue and Bone Sarcoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
SarcBOP - An interdisciplinary and translational registry
SarcBOP aims to establish a database that integrates every aspect possibly relevant to sarcoma treatment and research. SarcBOP thus will not be limited to specific questions or patient groups, but instead will build a comprehensive database including clinical, pathologic, and radiologic information, multi-layered molecular data, and patient-reported outcomes, combined with a dedicated biobank for tissue samples and liquid biopsies. As the study integrates seamlessly with the clinical activities of the Heidelberg Sarcoma Center, the Molecular Diagnostics Program of NCT Heidelberg, including the NCT/DKTK MASTER Program, and with the NCT Trial Center, including the PMO Clinical Trials Program, SarcBOP will generate a comprehensive and continuously growing resource for clinicians, researchers, and, finally, patients.
详细描述
The following data are collected and stored:
- Demographics
- Comorbidities
- Clinical characteristics at diagnosis, relapse and progression
- Radiologic images
- Histological images
- Treatments including DRG and OPS data, including detailed information on surgical, radiation, and medical therapy as well as treatment relevant follow-up data
- Longitudinal disease assessments
- Clinical outcome
- Genomic, transcriptomic, epigenomic and proteomic data
- Patient reported outcomes
Furthermore, biological samples are collected and processed by the Sample Processing Laboratory of the Heidelberg Center for Personalized Oncology and the NCT Biobank.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspected or proven diagnosis of soft-tissue or bone sarcoma (STBS)
- •Age ≥12 years
- •Ability to understand nature and individual consequences of the registry
- •Written informed consent
- •Subjects who are physically or mentally capable of giving consent
排除标准
- •Severe neurological or psychiatric disorder interfering with the ability to give written informed consent
结局指标
主要结局
overall survival
时间窗: 10 years
The length of time from the date of diagnosis disease, that patients diagnosed
次要结局
- progression free survival(5 years)
研究者
Prof. Dr. Richard F Schlenk
Head of NCT trials center and Clinical Trials
University Hospital Heidelberg