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临床试验/NCT03358212
NCT03358212Unknown不适用

Safety and Efficacy of Post-operative Denosumab Strategy for Giant Cell Tumor of Bone Treatment in China:Correlation Between Recurrence and Drug Withdrawl

Peking University People's Hospital0 个研究点目标入组 100 人开始时间: 2018年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
100
主要终点
recurrence without metastasis

研究概览

简要总结

This prospective observational study is going to figure out the safety and efficacy of denosumab as an post-operative strategy.All the patients enrolled will take denosumab according to the protocols.We focus on the recurrence rate after the drug withdrawl and possibility of malignant transformation.

详细描述

This prospective observational study is going to figure out the safety and efficacy of denosumab as an post-operative strategy.

This study only included patients who meet all the following criteria: (1) With treatment-naïve sacral giant-cell tumor (GCT) firstly treated in our center (for referral patients, only those with definite diagnosis were included); (2) Being diagnosed with classic giant-cell tumor of bone (GCTB) by puncture pathology prior to treatment (for referral patients, definite diagnosis shall be made by the Pathology Department in our center through pathology consultation on tissue sections); (3) previously denosumab-naïve.

Data collection:The following data of patients included in this study were collected: (1) basic information: age, gender; (2) pathological data: puncture pathological diagnosis, and postoperative pathological findings; (3) the imaging findings (including X-ray, CT, Magnetic resonance(MR), Positron Emission Tomography-Computed Tomography(PET-CT)) and functional assessment of patients in the neoadjuvant denosumab group before and after the use of denosumab; (4) intraoperative blood loss, and duration of operation; (5) imaging findings in postoperative follow-up re-examination and outcome.

functional assessment: For sacral giant cell tumor:The Motor Urination defecation(MUD) scoring system published on Spine by our center in 2016 , which include three domains (motor function and sensation of lower limbs [M], urination and uriesthesia [U], and Defecation and rectal sensation [D]) with three items in each domain (each item can be scored by 0, 1, 2 or 3, and the maximum score is 27), was applied in the functional assessment of sacral nerves.

For GCT occurs in Limbs ,we use Musculoskeletal Tumor Society (MSTS) 93 to record the function.

研究设计

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

入排标准

年龄范围
16 Years 至 50 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • (1) With treatment-naïve sacral GCT firstly treated in our center (for referral patients, only those with definite diagnosis were included); (2)single center lesion (3) Being diagnosed with classic GCTB by puncture pathology prior to treatment (for referral patients, definite diagnosis shall be made by the Pathology Department in our center through pathology consultation on tissue sections); (4) previously denosumab-naïve.

排除标准

  • (1)primary malignant giant cell tumor of bone(2)radiation therapy in history(3)lung metastasis at first diagnosis

研究组 & 干预措施

denosumab used postoperatively

the postoperative denosumab group, including patients receiving denosumab after piecemeal intralesional curettage aided by digital subtraction angiography(DSA) and balloon occlusion of abdominal aorta;

干预措施: Denosumab (Drug)

结局指标

主要结局

recurrence without metastasis

时间窗: up to 2 years

CT or MR proof that the tumor relapse in the primary site by at least two radiologist

次要结局

  • metastasis without recurrence(up to 2 years)
  • death from other disease(up to 2 years)
  • death from giant cell tumor(up to 2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

GUO WEI

Chief of Musculoskeltal Tumor Center

Peking University People's Hospital

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