Health TrialsbyHealthPanel

Outcomes Following Limb Sparing Surgery for Soft Tissue Sarcoma

ConditionSoft Tissue Sarcoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAmsterdam UMC

About this trial

The goal of this study is to assess body image, health-related quality of life (QoL), and functioning (gait function, joint function, and walking ability) in patients after resection of localized soft tissue sarcoma (STS) of the extremities. A secondary objective is to assess the influence of different variables (e.g., radiotherapy, ethnicity, etc.) on body image, health-related QoL, and functioning.

Patients who underwent a surgical resection at the Amsterdam UMC between 2010 and 2021 will be approached to participate in the study. Participants will complete four questionnaires and undergo a physical examination. Additionally, they will have a 3D gait analysis, a 6-minute walk test with gas analysis, and a muscle strength assessment. Furthermore, muscle volume change will be evaluated on pre- versus postoperative MRI scans.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Treated with surgical resection for primary non-metastatic extremity STS at the Amsterdam UMC between 2010-2021.

Being able to visit the Amsterdam UMC, location AMC once or twice.

Pregnant patients must agree to be scheduled 5 months after their pregnancy ends.

Disqualifiers

Patients who cannot maintain 6 minutes of walking will be excluded from the 6-minute walk test.

Trial population

Patients treated for primary non-metastatic extremity STS through surgical resection, with or without (neo-) adjuvant radiotherapy, between 2010-2021.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • Surgical resection with or without radiotherapy and/or chemotherapy

    Procedure/Surgery

    The surgical resection of STS serves as the primary treatment, aiming to completely remove the tumor with a wide margin of surrounding healthy tissue to minimize the risk of recurrence. Radiotherapy and/or chemotherapy may be incorporated depending on the tumor's type, stage, and grade.

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: Survivors following the resection of extremity soft tissue sarcoma1 intervention

Trial outcomes

Primary outcomes

1

Gait biomechanics

A 3D gait analysis will be conducted. Ground reaction forces will be captured using two force plates embedded in the center of the walkway. Three valid gait trials will be collected (meaning a clear strike on the force plate(s)). For each trial, data on joint angles and net joint moments (via inverse dynamics) and powers around the hip, knee, and ankle will be calculated. Data will be averaged over three trials to represent the outcome. Also, spatiotemporal gait parameters, such as step length (m) step width (m) and walking speed (m/s} will be calculated.

Time frame
Baseline
2

Range of motion in degrees

Rang of motion in degrees wil be assessed during the physical examination using a goniometer

Time frame
Baseline
3

Limb circumference in cm

Limb circumference in cm will be measured during the physical examination

Time frame
Baseline
4

Muscle strength in newton measured with a handheld dynamometer

A handheld dynamometer will be used to measure muscle strength during the physical examination. The participant will be asked to lie or to sit in a specific position and resistance will be applied depending on the muscle group to be tested. The dynamometer will be held perpendicular to the tested limb and the participant will be asked to actively perform a maximum contraction against the dynamometer. The participants will be instructed to push as hard as they can, and the examiner will apply equal force to that of the participant. On each muscle group, three trials will be performed, and the highest record among the three trials will be recorded. Newton (N) will be used to express muscle strength.

Time frame
Baseline

Secondary outcomes

1

Patient demographics

At baseline patiënt demographics (e.g age, sex, marital status, educational level, occupational status, ethnicity, country of origin and smoking status) will be collected

Time frame
Baseline
2

Body Mass Index (BMI) in kg/m2

BMI in kg/m² will be calculated as weight (kg) divided by height squared (m²)

Time frame
Baseline
3

Tumor characteristics

At baseline, tumor characteristics (e.g. tumor subtype, grade, stage and location) will be collected.

Time frame
Baseline
4

Tumor size in cm

Tumor size in cm will be measured on the pre-operative MRI scan

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Amsterdam UMC

Lead sponsor

Amsterdam UMC, location AMC

Sponsor institution

Source ClinicalTrials.gov
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