Soft Tissue SarcomaNCT06962072
Outcomes Following Limb Sparing Surgery for Soft Tissue Sarcoma
An observational study of Soft Tissue Sarcoma, run by Amsterdam UMC at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Soft Tissue Sarcoma
- What is being tested?
- Surgical resection with or without radiotherapy and/or chemotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteNetherlands
- Study dates
- 24 Apr 2025to 1 Jan 2028
- 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 treated for primary non-metastatic extremity STS through surgical resection, with or without (neo-) adjuvant radiotherapy, between 2010-2021.
Who may be able to join
- 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.
Who cannot join
- Patients who cannot maintain 6 minutes of walking will be excluded from the 6-minute walk test.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Milad Makdis Mouso, Bachelor of medicine contact
About this study
Official title: Body Image, Health-related Quality of Life, and Function After Soft Tissue Sarcoma Resection
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.
Read the detailed description
Primary objectives :
- 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:
- Evaluate impairments in gait biomechanics.
- Evaluate impairments in joint function as determined by range of motion and muscle strength.
- Body structure:
- 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:
- Objectify activity limitations by walking speed, and energy cost.
- 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
- Soft Tissue Sarcoma
- Being tested
- Surgical resection with or without radiotherapy and/or chemotherapy
- Keywords
- Soft tissue sarcoma, Body image, Quality of life, Function, Functioning
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical resection with or without radiotherapy and/or chemotherapyProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Surgical resection with or without radiotherapy and/or chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Range of motion in degrees
Rang of motion in degrees wil be assessed during the physical examination using a goniometer
Measured: Baseline
Limb circumference in cm
Limb circumference in cm will be measured during the physical examination
Measured: Baseline
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.
Measured: Baseline
Muscle strength tested with the MRC scale
Based on the clinician's assessment of the normal strength of the muscle group under examination, the scale rates muscle strength on a scale of 0 to 5, with 0 representing no visible contraction and 5 representing a movement against complete resistance.
Measured: Baseline
Muscle strength in newton meters measured with a Biodex dynamometer.
Quantitative force of muscles in arms or legs will be assessed using a Biodex dynamometer. The measures will be performed on both sides. On each muscle group, three trials will be performed, and the highest recorded value will be used for the analysis. Peak torque will be calculated and recorded in newton meters (Nm). Peak torque is defined as the highest torque output produced by muscle contraction during a repetition.
Measured: Baseline
Change in muscle volume between preoperative and postoperative MRI scans
The change in muscle volume between preoperative and postoperative MRI scans will be determined.
Measured: Baseline
Walking energy cost in J/kg/m
Walking energy cost in J/kg/m will be determined during a 6-minute walk test with simultaneous gas analysis. The oxygen uptake (VO2) and carbon dioxide production (VCO2) are measured breath-by-breath using a portable gas analysis system. First, the energy consumption will be measured for 8 minutes while the subjects are sitting on a chair. Then, the energy cost will be measured while subjects are walking during a 6-minute walk test at a comfortable, self-selected speed on an indoor oval route.
Measured: Baseline
Walking speed in m/s
Walking speed wil be assessed during the 6-minute walk test. It will be measured and calculated as the average speed over the steady state period.
Measured: Baseline
Time Up and Go (TUG) test
In the TUG test, the time (in seconds) required for a patient to get up from a chair, walk 3 meters to a marked point on the ground, turn, walk back to the chair, and sit down will be recorded.
Measured: Baseline
Timed Up and Down Stairs (TUDS) test
In the TUDS test, the time (in seconds) required for a patient to go up a flight of stairs quickly and safely, turn around on the top step, and descend to the bottom step with both feet landing on the ground will be recorded.
Measured: Baseline
Body image as assessed by the Body Image Scale (BIS)
Body image after STS resection will be evaluated with the Body Image Scale (BIS). This questionnaire consists of 10 questions about body image. For each question, the patient has to choose between 'not at all' (score 0), 'a little' (score 1), 'quite a bit' (score 2), and 'very much' (Score 3). In total, a score between 0 and 30 can be achieved with 0 indicating no distress or symptoms and 30 indicating the highest level of distress and symptoms
Measured: Baseline
Health-related quality of life (QoL) as assessed by the Patient Reported Outcome Measurement Information System-Computerized Adaptive Test (PROMIS-CAT)
Health-related QoL and activity limitations will be assessed using the PROMIS-CAT health domains: physical functioning, social role participation, pain interference, fatigue, upper extremity, and emotional distress (anxiety and depression). PROMIS instruments are scored with T-scores, which are standardized to the general population. The average of the reference population is set at 50 points, with a standard deviation of 10.
Measured: Baseline
Quality of life as assessed by the European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) questionnaire
This questionnaire is divided into two sections: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system consists of five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. There are five levels for each dimension. Patients will be asked to check the box next to the most suitable statement in every one of the five dimensions. For the EQ-VAS, patients will assess their health on a vertical visual analogue scale from 0 to 100 (0 being the worst and 100 being the best imaginable health).
Measured: Baseline
Level of pain as assessed by the Numeric Rating Scale (NRS)
The level of pain will be assessed using the Numeric Rating Scale (NRS) 0 to 10. The pain will be measured at four intervals, with 0 being no pain at all and 10 being the worst pain imaginable: currently (1), average last week (2), severity pain when worst (3) or least (4).
Measured: Baseline
Secondary outcomes (9)
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
Measured: Baseline
Body Mass Index (BMI) in kg/m2
BMI in kg/m² will be calculated as weight (kg) divided by height squared (m²)
Measured: Baseline
Tumor characteristics
At baseline, tumor characteristics (e.g. tumor subtype, grade, stage and location) will be collected.
Measured: Baseline
Tumor size in cm
Tumor size in cm will be measured on the pre-operative MRI scan
Measured: Baseline
Tumor volume in cm³
Tumor volume in cm³ will be measured on the pre-operative MRI scan
Measured: Baseline
Involvement of adjacent structures
Tumor invasion of adjacent stucrures will be assessed on the pre-operative MRI scan.
Measured: Baseline
Tumor depth
Tumor depth (deep or superficial) will be assessed on the pre-operative MRI scan.
Measured: Baseline
Treatments
At baseline, data on treatments (surgery, radiotherapy, and chemotherapy) will be recorded
Measured: Baseline
Complications
Treatment-related complications will be recorded.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start24 Apr 2025
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue SarcomaStudies 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
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Floortje Verspoor, Amsterdam UMC, location AMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06962072
- Sponsor's protocol ID
- NL85908.018.23
- Status last verified
- Apr 2025
- First submitted
- 28 Mar 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be made pubicly available but can be obtained upon request at the study's sponsor. When a valid reason for the re-use of study data is provided, a Data Sharing Agreement can be set up.
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Image, Health-related Quality of Life, and Function After Soft Tissue Sarcoma Resection
- ClinicalTrials.gov ID
- NCT06962072
- Acronym / sponsor ID
- NL85908.018.23
- Conditions
- Soft Tissue Sarcoma
- Keywords
- Soft tissue sarcoma, Body image, Quality of life, Function, Functioning
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Amsterdam UMCUniversity, hospital or other
- Study start
- 24 Apr 2025 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 8 May 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.
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.
Detailed description
Primary objectives :
- 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:
- Evaluate impairments in gait biomechanics.
- Evaluate impairments in joint function as determined by range of motion and muscle strength.
- Body structure:
- 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:
- Objectify activity limitations by walking speed, and energy cost.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Survivors following the resection of extremity soft tissue sarcoma | – | Procedure: Surgical resection with or without radiotherapy and/or chemotherapyPatients who were treated with surgical resection for primary non-metastatic extremity STS at the Amsterdam UMC between 2010 and 2021. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated for primary non-metastatic extremity STS through surgical resection, with or without (neo-) adjuvant radiotherapy, between 2010-2021.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients who cannot maintain 6 minutes of walking will be excluded from the 6-minute walk test.
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 |
|---|---|---|
| Surgical resection with or without radiotherapy and/or chemotherapyThe 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. | Procedure or surgery | Survivors following the resection of extremity soft tissue sarcoma |
Primary outcome
Gait biomechanics
Time frame: Baseline
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.
Range of motion in degrees
Time frame: Baseline
Rang of motion in degrees wil be assessed during the physical examination using a goniometer
Limb circumference in cm
Time frame: Baseline
Limb circumference in cm will be measured during the physical examination
Muscle strength in newton measured with a handheld dynamometer
Time frame: Baseline
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.
Muscle strength tested with the MRC scale
Time frame: Baseline
Based on the clinician's assessment of the normal strength of the muscle group under examination, the scale rates muscle strength on a scale of 0 to 5, with 0 representing no visible contraction and 5 representing a movement against complete resistance.
Muscle strength in newton meters measured with a Biodex dynamometer.
Time frame: Baseline
Quantitative force of muscles in arms or legs will be assessed using a Biodex dynamometer. The measures will be performed on both sides. On each muscle group, three trials will be performed, and the highest recorded value will be used for the analysis. Peak torque will be calculated and recorded in newton meters (Nm). Peak torque is defined as the highest torque output produced by muscle contraction during a repetition.
Change in muscle volume between preoperative and postoperative MRI scans
Time frame: Baseline
The change in muscle volume between preoperative and postoperative MRI scans will be determined.
Walking energy cost in J/kg/m
Time frame: Baseline
Walking energy cost in J/kg/m will be determined during a 6-minute walk test with simultaneous gas analysis. The oxygen uptake (VO2) and carbon dioxide production (VCO2) are measured breath-by-breath using a portable gas analysis system. First, the energy consumption will be measured for 8 minutes while the subjects are sitting on a chair. Then, the energy cost will be measured while subjects are walking during a 6-minute walk test at a comfortable, self-selected speed on an indoor oval route.
Walking speed in m/s
Time frame: Baseline
Walking speed wil be assessed during the 6-minute walk test. It will be measured and calculated as the average speed over the steady state period.
Time Up and Go (TUG) test
Time frame: Baseline
In the TUG test, the time (in seconds) required for a patient to get up from a chair, walk 3 meters to a marked point on the ground, turn, walk back to the chair, and sit down will be recorded.
Timed Up and Down Stairs (TUDS) test
Time frame: Baseline
In the TUDS test, the time (in seconds) required for a patient to go up a flight of stairs quickly and safely, turn around on the top step, and descend to the bottom step with both feet landing on the ground will be recorded.
Body image as assessed by the Body Image Scale (BIS)
Time frame: Baseline
Body image after STS resection will be evaluated with the Body Image Scale (BIS). This questionnaire consists of 10 questions about body image. For each question, the patient has to choose between 'not at all' (score 0), 'a little' (score 1), 'quite a bit' (score 2), and 'very much' (Score 3). In total, a score between 0 and 30 can be achieved with 0 indicating no distress or symptoms and 30 indicating the highest level of distress and symptoms
Health-related quality of life (QoL) as assessed by the Patient Reported Outcome Measurement Information System-Computerized Adaptive Test (PROMIS-CAT)
Time frame: Baseline
Health-related QoL and activity limitations will be assessed using the PROMIS-CAT health domains: physical functioning, social role participation, pain interference, fatigue, upper extremity, and emotional distress (anxiety and depression). PROMIS instruments are scored with T-scores, which are standardized to the general population. The average of the reference population is set at 50 points, with a standard deviation of 10.
Quality of life as assessed by the European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) questionnaire
Time frame: Baseline
This questionnaire is divided into two sections: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system consists of five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. There are five levels for each dimension. Patients will be asked to check the box next to the most suitable statement in every one of the five dimensions. For the EQ-VAS, patients will assess their health on a vertical visual analogue scale from 0 to 100 (0 being the worst and 100 being the best imaginable health).
Level of pain as assessed by the Numeric Rating Scale (NRS)
Time frame: Baseline
The level of pain will be assessed using the Numeric Rating Scale (NRS) 0 to 10. The pain will be measured at four intervals, with 0 being no pain at all and 10 being the worst pain imaginable: currently (1), average last week (2), severity pain when worst (3) or least (4).
9 secondary outcomes
Patient demographics
Time frame: Baseline
Body Mass Index (BMI) in kg/m2
Time frame: Baseline
Tumor characteristics
Time frame: Baseline
Tumor size in cm
Time frame: Baseline
Tumor volume in cm³
Time frame: Baseline
Involvement of adjacent structures
Time frame: Baseline
Tumor depth
Time frame: Baseline
Treatments
Time frame: Baseline
Complications
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Individual participant dataSharing planned: No. IPD will not be made pubicly available but can be obtained upon request at the study's sponsor. When a valid reason for the re-use of study data is provided, a Data Sharing Agreement can be set up.
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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.
Milad Makdis Mouso, Bachelor of medicine contact
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, run by Amsterdam UMC at 1 site in Netherlands.
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 3 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 19 Dec 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 Netherlands. 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 Floortje G.M. Verspoor, MD/PhD (+310205669111, f.g.verspoor@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait biomechanics (time frame: Baseline). The study lists 15 primary outcomes in all. 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 19 Dec 2025.