SarcomaNCT04327908
Translation and Validation of the German Version of the Toronto Extremity Salvage Score (TESS) and Musculoskeletal Tumor Society (MSTS)
An observational study of Sarcoma, run by Medical University Innsbruck.
Trial summary
The MSTS is an evaluation tool used worldwide to assess physical function in patients with musculoskeletal tumors. The questionnaire has already been successfully translated and validated in Portuguese and Japanese. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcoma
- What is being tested?
- Questionaire TESS and MSTS
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2020to 1 Jun 2023
- 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 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing a limb-salvage procedere in orthopedic oncology surgeries.
Who may be able to join
- The questionnaire will be tested on patients who are undergoing extremity-conserving surgery for sarcomas at one of the participating centers as part of the clinical routine. The patients are addressed preoperatively by a member of the study team and during their stay in the clinic whether they participate in the study.
Who cannot join
- Patients who cannot be treated for extremities and patients who are unable to consent are excluded from the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Cross-cultural Adaptation, Translation and Validation of the German Version of the Toronto Extremity Salvage Score (TESS) and Musculoskeletal Tumor Society (MSTS) for Patients With Bone and Soft Tissue Sarcoma in German Speaking
The MSTS is an evaluation tool used worldwide to assess physical function in patients with musculoskeletal tumors. The questionnaire has already been successfully translated and validated in Portuguese and Japanese.
Both the TESS and the MSTS have already been used in many studies that examined bone and soft tissue tumors - also in German-speaking populations. So far, however, there is no validated German version of these questionnaires.
The aim of the study at hand is to translate the TESS and the MSTS into German and to validate them for patients with bone and soft tissue tumors / sarcomas.
Read the detailed description
The most common primary bone tumors include osteosarcoma, Ewing's sarcoma and chondrosarcoma. The main symptom in patients with primary bone tumors is pain that can occur at rest or at night. The physical examination often shows swelling and restricted movement of the joints. Malignant bone tumors require multidisciplinary treatment that focuses on the surgical removal of the tumor. The extremity-preserving procedure contrasts with the amputation. Studies show that the functional result after restoration of the limb is superior to the amputation and that the relapse rate and mortality are comparable in both procedures. The goal of tumor resection is therefore to keep the treatment-related restrictions as low as possible, especially with regard to quality of life, function of the extremity and recurrence-free survival of the patients. The improvement of the functional results and longevity of reconstructive procedures remains a major challenge.
The same applies to the treatment of soft tissue sarcomas. However, early diagnosis is often hampered by atypical symptoms such as soft tissue swelling, painful lesions or no symptoms at all and is reported in the literature with an average period of time until the final diagnosis of 3 to 6 months. En bloc resection is the treatment of choice. Radiation therapy, chemotherapy and isolated hyperthermic limb perfusion can be used depending on tumor histology, degree and extent.
The measurement of the clinical outcome is of great importance. In order to objectify, measure and compare the success or failure of treatment with current literature and other tumor centers and to evaluate the invasive surgical procedures. Questionnaires such as the Toronto Extremity Salvage Score (TESS) and the Musculoskeletal Tumor Society (MSTS) were developed to measure the functional results after surgery and heterogeneity.
The TESS is a valid and disease-specific measure for evaluating functional disorders in patients between 12-85 years of age who are treated surgically for a bone or soft tissue sarcoma of the extremities. The questionnaire measures parameters such as Mobility, independence in everyday life, participation in social life and the pursuit of leisure activities. There is a version for the upper and one for the lower extremity with 30 questions each. Each question is rated on a 1-5 scale, with 5 being the value for normal performance. So far there have been studies to validate the TESS in Portuguese, Danish, Korean and Japanese.
The MSTS is an evaluation tool used worldwide to assess physical function in patients with musculoskeletal tumors. The questionnaire has already been successfully translated and validated in Portuguese and Japanese.
Both the TESS and the MSTS have already been used in many studies that examined bone and soft tissue tumors - also in German-speaking populations. So far, however, there is no validated German version of these questionnaires.
The aim of the study at hand is to translate the TESS and the MSTS into German and to validate them for patients with bone and soft tissue tumors / sarcomas.
- Conditions
- Sarcoma
- Being tested
- Questionaire TESS and MSTS
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionaire TESS and MSTSOther
answering TESS and MSTS questionnaire
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of psychometric properties of questionnaire MSTS and TESS in German translation
Patient Reported Outcome Measurements: DASH, HHS, WOMAC, SF12v2 e.g.
Measured: one day
Secondary outcomes (1)
Define questionnaires content validité: évaluation of translation quality
Patient Reported Outcome Measurements: DASH, HHS, WOMAC, SF12v2 e.g.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start1 Jun 2020 (estimated)
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dammerer Dietmar, MD, Medical University Innsbruck
- Investigators
- Dietmar Dammerer, MD, MSc, PhD, Principal investigator, Medical University of Innsbruck, Dept. Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04327908
- Sponsor's protocol ID
- 1/2020
- Status last verified
- Mar 2020
- First submitted
- 27 Mar 2020
- Last updated
- 1 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-cultural Adaptation, Translation and Validation of the German Version of the Toronto Extremity Salvage Score (TESS) and Musculoskeletal Tumor Society (MSTS) for Patients With Bone and Soft Tissue Sarcoma in German Speaking
- ClinicalTrials.gov ID
- NCT04327908
- Acronym / sponsor ID
- 1/2020
- Conditions
- Sarcoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 31 Mar 2020 (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 MSTS is an evaluation tool used worldwide to assess physical function in patients with musculoskeletal tumors. The questionnaire has already been successfully translated and validated in Portuguese and Japanese.
Both the TESS and the MSTS have already been used in many studies that examined bone and soft tissue tumors - also in German-speaking populations. So far, however, there is no validated German version of these questionnaires.
The aim of the study at hand is to translate the TESS and the MSTS into German and to validate them for patients with bone and soft tissue tumors / sarcomas.
Detailed description
The most common primary bone tumors include osteosarcoma, Ewing's sarcoma and chondrosarcoma. The main symptom in patients with primary bone tumors is pain that can occur at rest or at night. The physical examination often shows swelling and restricted movement of the joints. Malignant bone tumors require multidisciplinary treatment that focuses on the surgical removal of the tumor. The extremity-preserving procedure contrasts with the amputation. Studies show that the functional result after restoration of the limb is superior to the amputation and that the relapse rate and mortality are comparable in both procedures. The goal of tumor resection is therefore to keep the treatment-related restrictions as low as possible, especially with regard to quality of life, function of the extremity and recurrence-free survival of the patients. The improvement of the functional results and longevity of reconstructive procedures remains a major challenge.
The same applies to the treatment of soft tissue sarcomas. However, early diagnosis is often hampered by atypical symptoms such as soft tissue swelling, painful lesions or no symptoms at all and is reported in the literature with an average period of time until the final diagnosis of 3 to 6 months. En bloc resection is the treatment of choice. Radiation therapy, chemotherapy and isolated hyperthermic limb perfusion can be used depending on tumor histology, degree and extent.
The measurement of the clinical outcome is of great importance. In order to objectify, measure and compare the success or failure of treatment with current literature and other tumor centers and to evaluate the invasive surgical procedures. Questionnaires such as the Toronto Extremity Salvage Score (TESS) and the Musculoskeletal Tumor Society (MSTS) were developed to measure the functional results after surgery and heterogeneity.
The TESS is a valid and disease-specific measure for evaluating functional disorders in patients between 12-85 years of age who are treated surgically for a bone or soft tissue sarcoma of the extremities. The questionnaire measures parameters such as Mobility, independence in everyday life, participation in social life and the pursuit of leisure activities. There is a version for the upper and one for the lower extremity with 30 questions each. Each question is rated on a 1-5 scale, with 5 being the value for normal performance. So far there have been studies to validate the TESS in Portuguese, Danish, Korean and Japanese.
The MSTS is an evaluation tool used worldwide to assess physical function in patients with musculoskeletal tumors. The questionnaire has already been successfully translated and validated in Portuguese and Japanese.
Both the TESS and the MSTS have already been used in many studies that examined bone and soft tissue tumors - also in German-speaking populations. So far, however, there is no validated German version of these questionnaires.
The aim of the study at hand is to translate the TESS and the MSTS into German and to validate them for patients with bone and soft tissue tumors / sarcomas.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing a limb-salvage procedere in orthopedic oncology surgeries.
Key inclusion criteria (1 listed)
- The questionnaire will be tested on patients who are undergoing extremity-conserving surgery for sarcomas at one of the participating centers as part of the clinical routine. The patients are addressed preoperatively by a member of the study team and during their stay in the clinic whether they participate in the study.
Key exclusion criteria (1 listed)
- Patients who cannot be treated for extremities and patients who are unable to consent are excluded from the study.
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 |
|---|---|---|
| Questionaire TESS and MSTSanswering TESS and MSTS questionnaire | Other | – |
Primary outcome
Validation of psychometric properties of questionnaire MSTS and TESS in German translation
Time frame: one day
Patient Reported Outcome Measurements: DASH, HHS, WOMAC, SF12v2 e.g.
1 secondary outcome
Define questionnaires content validité: évaluation of translation quality
Time frame: one day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2020.
- Individual participant dataSharing planned: No
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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.
Dietmar Dammerer, MD, MSc, PhD principal investigator
Medical University of Innsbruck, Dept. Orthopaedics
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoma, run by Medical University Innsbruck.
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: status not confirmed, as of the sponsor's last update on 1 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dietmar Dammerer, MD,MSc,PhD (0043512504 ext. 2261, dietmar.dammerer@tirol-kliniken.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of psychometric properties of questionnaire MSTS and TESS in German translation (time frame: one day). 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 1 Apr 2020.