Electrochemotherapy in Musculoskeletal Tumors: A Quantitative Assessment of Tumor Size Variations and Treatment-related Pain Reduction.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Tumor size will be assessed using CT, MRI, X-ray, and/or PET imaging. Tumor size will be defined as the longest diameter of the target lesion (mm).
研究概览
简要总结
The study involves the enrollment of patients over 2 years of age with a diagnosis of musculoskeletal tumors and an indication for electrochemotherapy, treated at the Rizzoli Orthopaedic Institute in Bologna and followed during outpatient follow-up. Data will be collected from medical records, outpatient reports, and imaging studies including CT, X-ray, MRI, and/or PET.
For the retrospective part of the study, patients treated at the Rizzoli Orthopaedic Institute from 01/01/2024 to the date of approval of this study will be included. For the prospective part, patients meeting the inclusion criteria and treated from the study start date until 31/12/2030 will be enrolled.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes with a histological diagnosis of a primary musculoskeletal tumor, either benign or malignant, located outside the abdominal cavity (trunk and limbs)
- •Indication for electrochemotherapy due to one of the following conditions:
- •Clinical conditions contraindicating surgery
- •Tumor not surgically resectable
- •Patients treated with electrochemotherapy at the Rizzoli Orthopaedic Institute:
- •From 01/01/2024 to the date of study approval for the retrospective phase
- •From the date of study approval to 12/31/2030 for the prospective phase
- •Retrospectively treated patients with a minimum follow-up of at least 3 months
- •Age ≥ 2 years at the time of treatment
- •Availability of clinical and instrumental data
排除标准
- •Failure to meet at least one of the inclusion criteria
结局指标
主要结局
Tumor size will be assessed using CT, MRI, X-ray, and/or PET imaging. Tumor size will be defined as the longest diameter of the target lesion (mm).
时间窗: 3, 6, and 12 months after electrochemotherapy
次要结局
- Change from baseline in pain intensity measured by the Visual Analog Scale (VAS), ranging from 0 to 10, where higher scores indicate worse pain, at 3, 6, and 12 months after electrochemotherapy.Number of participants with treatment-related adverse events(3, 6, and 12 months after treatment)
研究者
Costantino Errani
Principal Investigator
Istituto Ortopedico Rizzoli