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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
  • IRCCS AOU di Bologna Policlinico di Sant'Orsola

    Bologna, Italia, 40138

    Mauro Prof Gargiulo, MD, 0512143288, mauro.gargiulo2@unibo.it

    Recruiting

Other trials in Italy

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.

  1. 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.

  1. First posted10 Feb 2025
  2. Study start21 Jun 2023
  3. Primary completion31 Mar 2025 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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)
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

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.

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