Soft Tissue Sarcoma (STS)SARCOVASCPLASTNCT07093320
Saving Limbs After Cancer: Blood Vessel and Soft Tissue Reconstruction Following Sarcoma Surgery in the Legs
An observational study of Soft Tissue Sarcoma (STS), run by European Georges Pompidou Hospital at 1 site in France.
Trial summary
This study aimed to evaluate whether immediate reconstruction of blood vessels and soft tissues can safely and effectively preserve limbs in patients undergoing surgery for sarcomas involving major arteries or veins in the arms or legs. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Soft Tissue Sarcoma (STS)
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2019to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Tertiary center (sarcoma reference center), teaching hospital
Who may be able to join
- All consecutive patient presented with STS with major vessels involvement
Who cannot join
- All STS without major vessels involvement
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Chirurgie Plastique, Reconstructrice et Esthétique, Hôpital Européen Georges Pompidou
Paris, 75
About this study
Official title: Immediate Vascular and Soft Tissue Reconstruction After Sarcoma Resection Involving Major Limb Vessels: Early and Midterm Outcomes From a Tertiary Center
This study aimed to evaluate whether immediate reconstruction of blood vessels and soft tissues can safely and effectively preserve limbs in patients undergoing surgery for sarcomas involving major arteries or veins in the arms or legs. The goal was to determine if this complex surgical approach helps avoid amputation, ensures good cancer control, and leads to acceptable complication rates and healing outcomes.
- Conditions
- Soft Tissue Sarcoma (STS)
- Being tested
- No intervention
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| STS with major vessel involvement | STS with major vessel involvement Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
1- Limb salvage rate 2- Flap survival 3- Vascular patency
- Limb salvage: Determined by clinical documentation of limb preservation without major amputation.
- Flap survival: Determined by clinical evaluation of flap viability
- Vascular patency: Determined by duplex ultrasonography or CT angiography.
Measured: At 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start1 Dec 2019
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue Sarcoma (STS)Studies 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
- Retrospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Georges Pompidou Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Lhuaire, European Georges Pompidou Hospital
- Investigators
- Martin LHUAIRE, MD, Msc, Principal investigator, Service de Chirurgie Plastique, Reconstructrice et Esthétique, Hôpital Européen Georges Pompidou Paris, , France 75015Laurent Lantieri, MD, Study chair, Service de Chirurgie Plastique, Reconstructrice et Esthétique, Hôpital Européen Georges Pompidou Paris, , France 75015David BIAU, MD, PhD, Study director, Service de Chirurgie Orthopédique et oncoorthopédie, Hôpital Cochin, Paris, , France 75015
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093320
- Sponsor's protocol ID
- SARCOVAPLAST
- Other IDs
- number IRB 00006477
- Acronym
- SARCOVASCPLAST
- Status last verified
- Jul 2025
- First submitted
- 15 Jul 2025
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Vascular and Soft Tissue Reconstruction After Sarcoma Resection Involving Major Limb Vessels: Early and Midterm Outcomes From a Tertiary Center
- ClinicalTrials.gov ID
- NCT07093320
- Acronym / sponsor ID
- SARCOVASCPLAST / SARCOVAPLAST
- Conditions
- Soft Tissue Sarcoma (STS)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- European Georges Pompidou HospitalUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 30 Jul 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.
This study aimed to evaluate whether immediate reconstruction of blood vessels and soft tissues can safely and effectively preserve limbs in patients undergoing surgery for sarcomas involving major arteries or veins in the arms or legs. The goal was to determine if this complex surgical approach helps avoid amputation, ensures good cancer control, and leads to acceptable complication rates and healing outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STS with major vessel involvement | – | Other: No interventionSTS with major vessel involvement |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Tertiary center (sarcoma reference center), teaching hospital
Key inclusion criteria (1 listed)
- All consecutive patient presented with STS with major vessels involvement
Key exclusion criteria (1 listed)
- All STS without major vessels involvement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | STS with major vessel involvement |
Primary outcome
1- Limb salvage rate 2- Flap survival 3- Vascular patency
Time frame: At 12 months postoperatively
1. Limb salvage: Determined by clinical documentation of limb preservation without major amputation. 2. Flap survival: Determined by clinical evaluation of flap viability 3. Vascular patency: Determined by duplex ultrasonography or CT angiography.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Individual participant dataSharing planned: Yes
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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.
Martin LHUAIRE, MD, Msc principal investigator
Service de Chirurgie Plastique, Reconstructrice et Esthétique, Hôpital Européen Georges Pompidou Paris, , France 75015
Laurent Lantieri, MD study chair
Service de Chirurgie Plastique, Reconstructrice et Esthétique, Hôpital Européen Georges Pompidou Paris, , France 75015
David BIAU, MD, PhD study director
Service de Chirurgie Orthopédique et oncoorthopédie, Hôpital Cochin, Paris, , France 75015
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 Soft Tissue Sarcoma (STS), run by European Georges Pompidou Hospital at 1 site in France.
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 1 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: finished, as of the sponsor's last update on 30 Jul 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
1- Limb salvage rate 2- Flap survival 3- Vascular patency (time frame: At 12 months postoperatively). 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 30 Jul 2025.