Muscle CancerIOVA-mstNCT06818552
The Role of the Vascular Surgeon in Orthopedic Surgery of Musculoskeletal Tumors
An observational study of Muscle Cancer, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
Very large musculoskeletal tumors frequently involve vascular structures. Literature data show that spinal surgery and orthopedic surgery are the specialist branches that most frequently require intraoperative vascular surgical assistance, with 33.8% and 26.4% of requests, respectively6. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Cancer
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 21 Jun 2023to 31 Dec 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with musculoskeletal tumor with involvement of vascular structures and indication for surgical treatment of removal of the mass that requires the presence of a vascular surgeon. This indication is supported by international guidelines and represents normal clinical practice in these patients.
Who may be able to join
- Patient diagnosed with musculoskeletal tumor involving vascular structures requiring surgical removal
- Planned surgical treatment with intraoperative assistance of the vascular surgeon
- Obtaining informed consent
- Age 18 years
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS AOU di Bologna Policlinico di Sant'Orsola
Bologna, Italia, 40138
Mauro Prof Gargiulo, MD, 0512143288, mauro.gargiulo2@unibo.it
About this study
Very large musculoskeletal tumors frequently involve vascular structures. Literature data show that spinal surgery and orthopedic surgery are the specialist branches that most frequently require intraoperative vascular surgical assistance, with 33.8% and 26.4% of requests, respectively6.
In these cases, the surgical assistance of the vascular surgeon allows the safe removal of the mass, the possible repair of vessels damaged during cleavage and isolation of the mass, the ligation or complete reconstruction of the involved vascular segment and contributes to reducing intraoperative and postoperative complications7.
Read the detailed description
Musculoskeletal tumors and spinal tumors represent a large and heterogeneous group of neoplasms. They are divided into primary soft tissue tumors (deriving from the neoplastic transformation of muscle, connective, vascular, lymphatic, nervous and adipose cells), primary bone tumors (deriving from the precursor cells of bone and cartilage cells) and spinal tumors. These neoplasms, depending on their location, can be either benign (chondroblastoma, chondromyxofibroma, enchondroma, fibrous dysplasia, benign giant cell tumor, non-ossifying fibroma, osteoblastoma, osteochondroma, osteoid osteoma, hemangioma, aneurysmal cyst, eosinophilic granuloma) or malignant (soft tissue sarcomas, osteosarcomas, chondrosarcomas, chondromas, Ewing's sarcoma, fibrosarcoma and undifferentiated pleomorphic sarcomas of the bone, myeloma/plasmacytoma, chordoma, meningioma, neurofibroma and schwannoma).
The initial presentation is frequently related to the mass effect that these tumors cause when they reach large dimensions. Equally often, particularly in the case of bone tumors, pain and pathological fractures represent the initial symptoms.
Both soft tissue and bone sarcomas are rare diseases with an incidence of 5 cases per 100,000 and 1 case per 100,000 inhabitants, respectively (data from AIRC - Italian Association for Cancer Research)1.
Due to their cellular heterogeneity, these tumors can be located in different areas of the human body, with a preference for the trunk and limbs; and they are often infiltrating in nature.
Their treatment is based, depending on the histotype and the degree of disease at the time of diagnosis, on surgical removal of the tumor, chemotherapy (CT), radiotherapy (RT) or a combination of these different methods.
The 5-year survival of these tumors varies, in addition to the histotype and degree, also on the experience of the center where the treatment takes place; and is estimated at around 70% for soft tissue sarcomas, 60% in localized forms of osteosarcoma and 80% in localized forms of chondrosarcoma2-4.
The radicality of the surgical treatment of these neoplasms is dictated in large part by obtaining wide resection margins that often involve surgical excisions extending beyond the structures directly involved by the tumor5.
Very extensive musculoskeletal tumors frequently involve vascular structures. Data from the literature show that spinal surgery and orthopedic surgery are the specialist branches that most frequently require intra-operative vascular surgical assistance, with 33.8% and 26.4% of requests, respectively6.
In these cases, the surgical assistance of the vascular surgeon allows the safe removal of the mass, the possible repair of the vessels damaged during the cleavage and isolation of the mass, the ligation or complete reconstruction of the involved vascular segment and contributes to reducing intra-operative and post-operative complications7.
The primary objective of the study is to evaluate the outcomes of the interventions for the removal of musculoskeletal tumors, in relation to the type of vascular surgical assistance provided.
- Conditions
- Muscle Cancer
- Medical subject headings
- Muscle Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of vascular issues during every procedure
Number of major and minor vascular complications are collected during every procedure
Measured: From the first patient entrolled up to the 70th patient, up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start21 Jun 2023
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle CancerStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mauro Gargiulo, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06818552
- Sponsor's protocol ID
- IOVA-mst
- Acronym
- IOVA-mst
- Status last verified
- Oct 2024
- First submitted
- 28 Nov 2024
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Vascular Surgeon in Orthopedic Surgery of Musculoskeletal Tumors
- ClinicalTrials.gov ID
- NCT06818552
- Acronym / sponsor ID
- IOVA-mst / IOVA-mst
- Conditions
- Muscle Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 21 Jun 2023 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Feb 2025 (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.
Very large musculoskeletal tumors frequently involve vascular structures. Literature data show that spinal surgery and orthopedic surgery are the specialist branches that most frequently require intraoperative vascular surgical assistance, with 33.8% and 26.4% of requests, respectively6.
In these cases, the surgical assistance of the vascular surgeon allows the safe removal of the mass, the possible repair of vessels damaged during cleavage and isolation of the mass, the ligation or complete reconstruction of the involved vascular segment and contributes to reducing intraoperative and postoperative complications7.
Detailed description
Musculoskeletal tumors and spinal tumors represent a large and heterogeneous group of neoplasms. They are divided into primary soft tissue tumors (deriving from the neoplastic transformation of muscle, connective, vascular, lymphatic, nervous and adipose cells), primary bone tumors (deriving from the precursor cells of bone and cartilage cells) and spinal tumors. These neoplasms, depending on their location, can be either benign (chondroblastoma, chondromyxofibroma, enchondroma, fibrous dysplasia, benign giant cell tumor, non-ossifying fibroma, osteoblastoma, osteochondroma, osteoid osteoma, hemangioma, aneurysmal cyst, eosinophilic granuloma) or malignant (soft tissue sarcomas, osteosarcomas, chondrosarcomas, chondromas, Ewing's sarcoma, fibrosarcoma and undifferentiated pleomorphic sarcomas of the bone, myeloma/plasmacytoma, chordoma, meningioma, neurofibroma and schwannoma).
The initial presentation is frequently related to the mass effect that these tumors cause when they reach large dimensions. Equally often, particularly in the case of bone tumors, pain and pathological fractures represent the initial symptoms.
Both soft tissue and bone sarcomas are rare diseases with an incidence of 5 cases per 100,000 and 1 case per 100,000 inhabitants, respectively (data from AIRC - Italian Association for Cancer Research)1.
Due to their cellular heterogeneity, these tumors can be located in different areas of the human body, with a preference for the trunk and limbs; and they are often infiltrating in nature.
Their treatment is based, depending on the histotype and the degree of disease at the time of diagnosis, on surgical removal of the tumor, chemotherapy (CT), radiotherapy (RT) or a combination of these different methods.
The 5-year survival of these tumors varies, in addition to the histotype and degree, also on the experience of the center where the treatment takes place; and is estimated at around 70% for soft tissue sarcomas, 60% in localized forms of osteosarcoma and 80% in localized forms of chondrosarcoma2-4.
The radicality of the surgical treatment of these neoplasms is dictated in large part by obtaining wide resection margins that often involve surgical excisions extending beyond the structures directly involved by the tumor5.
Very extensive musculoskeletal tumors frequently involve vascular structures. Data from the literature show that spinal surgery and orthopedic surgery are the specialist branches that most frequently require intra-operative vascular surgical assistance, with 33.8% and 26.4% of requests, respectively6.
In these cases, the surgical assistance of the vascular surgeon allows the safe removal of the mass, the possible repair of the vessels damaged during the cleavage and isolation of the mass, the ligation or complete reconstruction of the involved vascular segment and contributes to reducing intra-operative and post-operative complications7.
The primary objective of the study is to evaluate the outcomes of the interventions for the removal of musculoskeletal tumors, in relation to the type of vascular surgical assistance provided.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with musculoskeletal tumor with involvement of vascular structures and indication for surgical treatment of removal of the mass that requires the presence of a vascular surgeon. This indication is supported by international guidelines and represents normal clinical practice in these patients.
Key inclusion criteria (4 listed)
- Patient diagnosed with musculoskeletal tumor involving vascular structures requiring surgical removal
- Planned surgical treatment with intraoperative assistance of the vascular surgeon
- Obtaining informed consent
- Age 18 years
Key exclusion criteria (1 listed)
- -
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
Number of vascular issues during every procedure
Time frame: From the first patient entrolled up to the 70th patient, up to 3 years
Number of major and minor vascular complications are collected during every procedure
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 10 Feb 2025.
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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.
Mauro Gargiulo, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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 Muscle Cancer, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna 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 4 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: looking for participants now, as of the sponsor's last update on 10 Feb 2025. 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?
Contact Mauro Gargiulo, MD (0512143288 ext. +39, mauro.gargiulo2@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of vascular issues during every procedure (time frame: From the first patient entrolled up to the 70th patient, up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.