NCT07093320

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2019

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 30, 2025

Completed
Last Updated

July 30, 2025

Status Verified

July 1, 2025

Enrollment Period

5.1 years

First QC Date

July 15, 2025

Last Update Submit

July 23, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 1- Limb salvage rate 2- Flap survival 3- Vascular patency

    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.

    At 12 months postoperatively

Study Arms (1)

STS with major vessel involvement

STS with major vessel involvement

Other: No intervention

Interventions

No intervention

STS with major vessel involvement

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Tertiary center (sarcoma reference center), teaching hospital

You may qualify if:

  • All consecutive patient presented with STS with major vessels involvement

You may not qualify if:

  • All STS without major vessels involvement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Chirurgie Plastique, Reconstructrice et Esthétique, Hôpital Européen Georges Pompidou

Paris, 75, France

Location

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Martin LHUAIRE, MD, Msc

    Service de Chirurgie Plastique, Reconstructrice et Esthétique, Hôpital Européen Georges Pompidou Paris, , France 75015

    PRINCIPAL INVESTIGATOR
  • Laurent Lantieri, MD

    Service de Chirurgie Plastique, Reconstructrice et Esthétique, Hôpital Européen Georges Pompidou Paris, , France 75015

    STUDY CHAIR
  • David BIAU, MD, PhD

    Service de Chirurgie Orthopédique et oncoorthopédie, Hôpital Cochin, Paris, , France 75015

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

July 15, 2025

First Posted

July 30, 2025

Study Start

December 1, 2019

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

July 30, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
12 months after publication of the data
Access Criteria
De-identified individual participant data (IPD) and supporting documentation will be made available by the Principal Investigator upon reasonable request from qualified researchers.
More information

Locations