Observational Study, for Quality Assessment, of Sarcoma As a Model to Improve Diagnosis and Clinical Care of Rare Tumors Through a European and Latin American Multidisciplinary NETWORK
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5,000
- 试验地点
- 9
- 主要终点
- Percentage of cases with > 5 cm with tru-cut biopsies.
研究概览
简要总结
Post-authorisation, multicentric, observational, retrospective and prospective study to assess quality of care of sarcoma patients in expert and non-expert centers by analysing correlation of quality items and outcomes such as relapse free survival, overall survival, percentage of amputation, etc.
Expert pathology peer review will be performed to detect differences between expert and non-expert centers as well as differences in treatment and patient prognosis.
Tumor samples of 4 types of sarcoma would also be included in translational research to detect biomarkers and produce preclinical models.
详细描述
Patients with an histological diagnosis of soft-tissue sarcoma, gastrointestinal stromal tumor (GIST) or bone sarcoma (all subtypes) with ≥ 18 years old are able to be included in the study.
Data registration period includes:
Retrospective part: from January 2012 until June 2019 Prospective part: from July 2019 until January 2022.
In all clinical practice guidelines, it is recommended to refer patients with suspected sarcomas to an Expert Center (EC). The pioneers in implementing EC in sarcomas have been the Scandinavian countries, where referral is mandatory. In Spain, through the Audit of the Ministry of Health, Social Affairs and Equality, 5 CSURs (Centers, Services or Reference Units). Taken together the previous information, and since the European experience in sarcoma EC and sarcoma referral policies have shown to be positive, as numerous outcome indicators favoring patients managed in EC have been reported, a European and Latin-American consortium of sarcoma centers has emerged, supported by Horizon 2020 program (Horizon 2020 Call: H2020-SC1-BHC-2018-2020) with the aim of implementing a process to facilitate the accreditation of expert centers in sarcoma as well as a network of Latin-American sarcoma centers.
A SELNET database is available for all participating countries. to register patient's clinical data: Demographic information, Type of sarcoma (Soft-tissue/Bone/GIST), Clinical presentation, Diagnosis, Treatment, and Survival and follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological diagnosis of soft-tissue sarcoma, GIST or bone sarcoma (all subtypes) from January 2005 until Juny/September
- •≥ 18 years
- •Available clinical and treatment information
排除标准
- •There is no exclusion criteria
结局指标
主要结局
Percentage of cases with > 5 cm with tru-cut biopsies.
时间窗: through study completion, an average of 3 years
tumor should be bigger than 5cm
Percentage of biopsies carried out by sarcoma teams vs not sarcoma team
时间窗: through study completion, an average of 3 years
in all the series and in cases with \> 5 cm
Percentage of patients with specified histopathological grade in pathologic report.
时间窗: through study completion, an average of 3 years
Using FNCLCC grade criteria
Percentage of affected surgical margins in first surgery
时间窗: through study completion, an average of 3 years
Using Enneking classification for determinations of surgical margins
percentage of patients with >5 cm and G2-3 sarcoma receiving neo/adjuvant radiotherapy
时间窗: through study completion, an average of 3 years
Using FNCLCC grade criteria
Percentage of patients with localized GIST with adequate risk assessment
时间窗: through study completion, an average of 3 years
Classifying risk with mitotic count (50HPF), site and size of primary tumor
Percentage of patients with advanced GIST with available molecular status of KIT/PDGFR before initiating systemic therapy for advanced disease
时间窗: through study completion, an average of 3 years
Detection of KIT/PDGFR y Sanger and or NGS
Percentage of patients with image studies at diagnosis and before surgery.
时间窗: through study completion, an average of 3 years
The same type of image should have been performed
Percentage of patients discussed in Multidisciplinary Team before treatment
时间窗: through study completion, an average of 3 years
multidisciplinary team includes serval departments at the same center
Percentage of re-resections in patients with affected surgical margins in first surgery
时间窗: through study completion, an average of 3 years
Using Enneking classification for determinations of surgical margins
次要结局
- Overall survival(through study completion, an average of 3 years)
- Surgical margins(through study completion, an average of 3 years)
- Percentage of amputation(through study completion, an average of 3 years)
- Relapse-free survival(tthrough study completion, an average of 3 years)