Bone TumorsNCT07323017
Electrochemotherapy in Musculoskeletal Tumors
An observational study of Bone Tumors, run by Costantino Errani at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Bone Tumors
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Aug 2025to 30 Jun 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- Failure to meet at least one of the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electrochemotherapy in Musculoskeletal Tumors: A Quantitative Assessment of Tumor Size Variations and Treatment-related Pain Reduction.
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.
- Conditions
- Bone Tumors
- Medical subject headings
- Bone Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3, 6, and 12 months after electrochemotherapy
Secondary outcomes (1)
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
Measured: 3, 6, and 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start1 Aug 2025
- Primary completion30 Dec 2030 (estimated)
- Study completion30 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bone TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Costantino Errani
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Costantino Errani, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07323017
- Sponsor's protocol ID
- ELECTRO
- Status last verified
- Jan 2026
- First submitted
- 10 Dec 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35323339Cevolani 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.
PubMed 36966436
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrochemotherapy in Musculoskeletal Tumors: A Quantitative Assessment of Tumor Size Variations and Treatment-related Pain Reduction.
- ClinicalTrials.gov ID
- NCT07323017
- Acronym / sponsor ID
- ELECTRO
- Conditions
- Bone Tumors
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Costantino ErraniUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 30 Dec 2030 (estimated)
- Study completion
- 30 Jun 2032 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (1 listed)
- Failure to meet at least one of the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Time frame: 3, 6, and 12 months after electrochemotherapy
1 secondary outcome
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
Time frame: 3, 6, and 12 months after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Results publication: PubMed 35323339Campanacci 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.
- Results publication: PubMed 36966436Cevolani 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Tumors, run by Costantino Errani at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: 3, 6, and 12 months after electrochemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07323017, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.