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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 3, 6, and 12 months after electrochemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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:
Patients treated with electrochemotherapy at the Rizzoli Orthopaedic Institute:
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
Exclusion Criteria:
• Failure to meet at least one of the inclusion criteria
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The study will include patients older than 2 years with a diagnosis of musculoskeletal tumors who are indicated 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 (CT, X-ray, MRI, and/or PET).
The retrospective part will include patients treated at the Rizzoli Orthopaedic Institute from January 1, 2024, to the date of study approval.
The prospective part will enroll patients meeting the inclusion criteria who will be treated from the study start date until December 31, 2030.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Irccs Istituto Ortopedico Rizzoli | Bologna | Emilia-Romagna | 40134 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35323339 | Result | Campanacci L, Cevolani L, De Terlizzi F, Saenz L, Ali N, Bianchi G, Donati DM. Electrochemotherapy Is Effective in the Treatment of Bone Metastases. Curr Oncol. 2022 Mar 4;29(3):1672-1682. doi: 10.3390/curroncol29030139. | |
| 36966436 | Result | Cevolani L, Campanacci L, Staals EL, Dozza B, Bianchi G, De Terlizzi F, Donati DM. Is the association of electrochemotherapy and bone fixation rational in patients with bone metastasis? J Surg Oncol. 2023 Jul;128(1):125-133. doi: 10.1002/jso.27247. Epub 2023 Mar 26. |
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| ID | Term |
|---|---|
| D001859 | Bone Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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