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临床试验/NCT06714773
NCT06714773已完成不适用

Grade 2 Chondrosarcoma Treated by Intralesional Curettage: Follow-up vs Resection

IRCCS Azienda Ospedaliero-Universitaria di Bologna1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2024年1月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
62
试验地点
1
主要终点
Tumor recurrence(%)

研究概览

简要总结

The goal of this observational study is to assess the oncological outcomes in patients diagnosed with grade 2 chondrosarcoma, treated with intralesional curettage, stratified into two cohorts: those subjected to follow up monitoring and those who have undergone subsequent surgical intervention.

详细描述

Large resection of the tumor is considered the treatment of choice in patients affected by grade 2 chondrosarcoma. Nonetheless, a preoperative diagnosis of a lower grade lesion (ChS grade 1) is not infrequent, thus making these patients treated with intralesional curettage. Intralesional curettage is a type of surgery in which the pathological component is removed from the affected bone and the resulting bone defects can be filled with bone substitutes or bone cement. Bone cortexes are left in place like a shell.

The results of this study could contribute to find the right therapeutic pathway in patients affected by grade 2 chondrosarcoma treated with intralesional curettage, in particular in patients who underwent further surgery (bone resection) or follow-up. Since outcome data are scarce in the literature, the results of this study could be used to assess the feasibility of a randomized controlled trial with the correct sample size.

It is an explorative, spontaneous, non-profit, retrospective, observational study.

It involves the pseudonymous data collection of all patients matching inclusion criteria. The data recorded in this study are extracted from the medical records of patients who regularly seek care from the medical unit during their routine clinical visits. Following a meticulous collection of patients' baseline data, the two therapeutic options (clinical monitoring or bone resection) in patients affected by grade 2 chondrosarcoma treated with intralesional curettage will be compared.

Data related to demographics, histologic and treatment data will be collected. Oncologic follow-up data will be also collected. In particular, data related to local recurrences, distant metastasis and survival will be evaluated.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with a diagnosis of grade 2 chondrosarcoma of the appendiceal skeleton in the definitive specimen;
  • Patients treated with intralesional curettage surgery;
  • Patients aged >=18 years;
  • Patients who were treated between 01/01/2008 and 31/12/2020.

排除标准

  • Patients diagnosed with grade 1 or 3 chondrosarcoma on the histological diagnosis of the operative specimen.
  • Patients undergoing wide resection as the primary treatment.
  • Patients with less than 12 months follow-up.

结局指标

主要结局

Tumor recurrence(%)

时间窗: 3 months, 6 months, 1 year, 2 years, 5 years, 10 years

It will be measured by: X-Rays, CT, MRI, PET CT scan

distant metastasis (%)

时间窗: 3 months, 6 months, 1 year, 2 years, 5 years, 10 years

It will be measured by: CT scan of the lungs, PET CT scan

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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