Outcomes Following Limb Sparing Surgery for Soft Tissue Sarcoma
NCT ID: NCT06962072
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
150 participants
OBSERVATIONAL
2025-04-24
2028-01-01
Brief Summary
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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.
Detailed Description
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* To assess body image, health-related QoL, self-reported activity limitations, and pain after STS resections as defined in the The International Classification of Functioning, Disability and Health (ICF) domains.
* To assess the functioning of the patients after STS resections as defined by the ICF domains of body function, body structure, and activities and participation:
* Body function:
1. Evaluate impairments in gait biomechanics.
2. Evaluate impairments in joint function as determined by range of motion and muscle strength.
* Body structure:
a. Evaluate muscle volume change on pre- and postoperative MRI scans and correlate these findings with body image, health-related quality of life, activity limitations, and functional impairments.
* Activities and participation:
1. Objectify activity limitations by walking speed, and energy cost.
2. Objectify balance and mobility as measured by Timed Up and Go (TUG) test and Timed Up and Down Stairs (TUDS) test.
Secondary objectives:
* To identify factors associated with body image, health-related QoL and functioning in extremity STS survivors.
* To compare body image, health-related QoL and functioning between patients who were treated with and without radiotherapy.
Srudy design:
This is a cross-sectional follow-up study. All records of consecutive non-metastatic extremity STS patients who underwent surgical resection between 2010 and 2021 at the Amsterdam UMC will be evaluated. Both deceased patients and survivors are included to obtain a realistic picture of the entire population. Survivors (approximately N = 125-150) will be approached to take part in this study by phone, followed by a letter explaining the study, including an informed consent form.
At baseline, patient demographics, tumor characteristics, diagnostics, and treatments will be collected. The participants can either fill out the self-reported questionnaires at home through the internet (using EPIC/Castor) or on a tablet at the outpatient clinic with the help of the investigator.
Participants will be invited to visit the outpatient clinic for a physical examination, which will include assessments of joint range of motion, limb circumference, balance, and mobility. Balance and mobility will be evaluated using the Timed Up and Go (TUG) test and the Timed Up and Down Stairs (TUDS) test. Muscle strength will be assessed using a hand-held dynamometer and the Medical Research Council (MRC) scale. Participants can complete the computer-based questionnaires at the outpatient clinic if not already completed at home. This part of the study will take place at the Department of Orthopedic Surgery and Sports Medicine.
Additionally, participants will undergo a 3D gait analysis to assess gait biomechanics, a muscle strength assessment using a Biodex dynamometer, and a 6-minute walk test to evaluate walking speed and energy cost. These assessments will be conducted at the Department of Rehabilitation.
Depending on the test, results will be compared as follows:
* Against general population means
* Between patients who have undergone upper and lower extremity STS resection
* Between the affected limb and the contralateral healthy limb
Additionally, the results from the objective functional tests and the MRI-scans (with tumor and pre- plus postoperative muscle specific features) will be correlated with body image and health-related QoL questionnaires. To identify factors associated with body image, health-related QoL, and functioning, we will assess whether the collected factors (baseline patients and tumor characteristics, treatments, and complications) are associated with better or worse outcomes of the questionnaires and the functional tests.
Conditions
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Keywords
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Survivors following the resection of extremity soft tissue sarcoma
Patients who were treated with surgical resection for primary non-metastatic extremity STS at the Amsterdam UMC between 2010 and 2021.
Surgical resection with or without radiotherapy and/or chemotherapy
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.
Interventions
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Surgical resection with or without radiotherapy and/or chemotherapy
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Amsterdam UMC
OTHER
Responsible Party
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Floortje Verspoor
Clinical researcher
Locations
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Amsterdam UMC
Amsterdam, , Netherlands
Countries
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Central Contacts
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Other Identifiers
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NL85908.018.23
Identifier Type: -
Identifier Source: org_study_id