Clinical Evaluation for Sarcoma Originated From Bone (CESOFB)
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ClinicalTrials.gov Identifier: NCT03358992
Recruitment Status : Unknown
Verified November 2018 by Peking University People's Hospital. Recruitment status was: Recruiting
First Posted : December 2, 2017
Last Update Posted : November 14, 2018
Peking University People's Hospital
Second Affiliated Hospital, School of Medicine, Zhejiang University
Response Evaluation Criteria in Solid Tumors (RECIST) are insensitive in evaluating primary sarcoma originated from bone treated with chemotherapy or targeted therapy, which did not have the definition of measurement methods either. This study evaluates whether clinical imaging findings of sarcoma after preoperative chemotherapy correlate with tumor responses by pathological evaluation by Huvos classifications and develops reliable, quantitative, clinical response criteria.
A total of 1570 lesions were evaluated by clinical imaging including X-ray, computed tomography, magnetic resonance imaging and bone scan or PET/CT preoperatively treated with chemotherapy. All patients had surgery in our center and get pathological evaluation by tumor necrosis rate. Statistical diversity analysis was performed by different pathological groups and Receiver Operating Characteristic Curves，ROC were done to find the dividing clinical parameters (Cut-off values) to distinguish different pathological groups.The cut-off values of change rate of maximum diameters of tumor located in extremities were 86%, 50.7% and 0.02% for Huvos Ⅳ,Ⅲ,ⅡandⅠgroups. The differentiation was not obvious using bone scan to distinguish different pathological responses. And the cut-off value for SUVmax value for Huvos Ⅲ,ⅡandⅠgroups were 60.7% and 31.4%.After Multidisciplinary discussion in multiple sites of China, we finally designed a evaluation system based on our data. This study is desgined to prospectively compare the sensitivity and specificity of this Clinical evaluation of primary sarcoma originated from bone with other clinical evaluation system,such as RECIST 1.1, Choi and PERCIST.
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Layout table for eligibility information
Ages Eligible for Study:
Child, Adult, Older Adult
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Biopsy proved high-grade osteosarcoma, who could follow routine chemo-protocol for osteosarcoma, could get enrolled.