Limb SalvageNCT02536053
Outcomes in Lower Extremity Soft Tissue Sarcoma Patients After Limb Salvage
An observational study of Limb Salvage, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
This study aims to: 1. validate the Finnish version of the Musculoskeletal Tumor Society scale and the Toronto Extremity Salvage Score lower extremity sections and to 2. assess the functional ability and health-related quality of life (HRQoL) of lower extremity sarcoma patients who have undergone limb salvage surgery. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Limb Salvage
- What is being tested?
- Limb salvage
- Type of treatment
- Surgery or procedure
- How many people
- 141 participants
- Where
- 1 siteFinland
- Study dates
- Dec 2015to 15 Jan 2020
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Lower extremity sarcoma patient who underwent limb-salvage surgery
Who may be able to join
- Lower extremity soft tissue sarcoma locating in between hip/gluteus to foot
- No metastasis at the time of diagnosis
- Undergone limb salvage surgery
- A minimum of 1 year follow-up
- Written consent
- Age > 18
Who cannot join
- Age <18
- No limb-salvage surgery due to sarcoma
Trial locations and contacts
1 site in 1 country.
Finland1 site
Cancer center, Helsinki University Hospital and University of Helsinki
Helsinki, Helsinki and Uusimaa, 00029
About this study
Official title: Functional Outcomes and Health Related Quality of Life in Lower Extremity Soft Tissue Sarcoma Patients After Limb Salvage: A Prospective Study
This study aims to:
- validate the Finnish version of the Musculoskeletal Tumor Society scale and the Toronto Extremity Salvage Score lower extremity sections and to
- assess the functional ability and health-related quality of life (HRQoL) of lower extremity sarcoma patients who have undergone limb salvage surgery.
Read the detailed description
The first purpose of this study is to validate the Finnish version of the Musculoskeletal Tumor Society scale and the Toronto Extremity Salvage Score upper extremity sections. The second purpose is to chart the functional capabilities and health-related quality of life (HRQoL) of upper extremity sarcoma patients who have undergone limb salvage surgery with local or free flaps.
Patient hospital records are retrospectively reviewed to chart the demographic and clinical data.
The recruitment of patient takes place at the outpatient clinic of Department of Oncology, Helsinki University Hospital. The study includes a cross-sectional assessment at one year follow-up with five validated questionnaires. A follow-up is conducted three years after surgery in the outpatient clinic.
- Conditions
- Limb Salvage
- Being tested
- Limb salvage
- Keywords
- [E04.100.814.603]
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Limb salvageProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity of the lower-limb Musculoskeletal Tumor Society score and the Toronto Extremity Salvage Score
The validity is studied
Measured: two to five years
Reliability of the lower-limb Musculoskeletal Tumor Society score and the Toronto Extremity Salvage Score
The test-retest reliability is studied
Measured: two to five years
Health-related quality of life after limb salvage
Assessment of health-related quality of life
Measured: two to five years
Assessment of the functional ability after limb salvage
Assessment of functional ability
Measured: two to five years
Secondary outcomes (4)
Quality of Life Questionnaire-Core 30
Health-related quality of life assessment
Measured: two to five years
The 15-dimensions health-related quality of life instrument
Health-related quality of life assessment
Measured: two to five years
The Musculoskeletal Tumor Society score lower extremity section
Functional assessment of the reconstructed limb
Measured: two to five years
The Toronto Extremity Salvage Score lower extremity section
Functional assessment of the reconstructed limb
Measured: two to five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2015 (estimated)
- Study startDec 2015
- Primary completion10 Jan 2020
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Limb SalvageStudies 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
- Prospective
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jussi Repo, Helsinki University Central Hospital
- Investigators
- Erkki J Tukiainen, MD, PhD, Study director, Helsinki University Hospital and University of HelsinkiCarl Blomqvist, MD, PhD, Study director, Helsinki University Hospital and University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02536053
- Sponsor's protocol ID
- 324/13/03/02/2014/2
- Status last verified
- Jan 2021
- First submitted
- 18 Aug 2015
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Outcomes and Health Related Quality of Life in Lower Extremity Soft Tissue Sarcoma Patients After Limb Salvage: A Prospective Study
- ClinicalTrials.gov ID
- NCT02536053
- Acronym / sponsor ID
- 324/13/03/02/2014/2
- Conditions
- Limb Salvage
- Keywords
- [E04.100.814.603]
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 31 Aug 2015 (estimated)
- 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.
This study aims to:
- validate the Finnish version of the Musculoskeletal Tumor Society scale and the Toronto Extremity Salvage Score lower extremity sections and to
- assess the functional ability and health-related quality of life (HRQoL) of lower extremity sarcoma patients who have undergone limb salvage surgery.
Detailed description
The first purpose of this study is to validate the Finnish version of the Musculoskeletal Tumor Society scale and the Toronto Extremity Salvage Score upper extremity sections. The second purpose is to chart the functional capabilities and health-related quality of life (HRQoL) of upper extremity sarcoma patients who have undergone limb salvage surgery with local or free flaps.
Patient hospital records are retrospectively reviewed to chart the demographic and clinical data.
The recruitment of patient takes place at the outpatient clinic of Department of Oncology, Helsinki University Hospital. The study includes a cross-sectional assessment at one year follow-up with five validated questionnaires. A follow-up is conducted three years after surgery in the outpatient clinic.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Lower extremity sarcoma patient who underwent limb-salvage surgery
Key inclusion criteria (6 listed)
- Lower extremity soft tissue sarcoma locating in between hip/gluteus to foot
- No metastasis at the time of diagnosis
- Undergone limb salvage surgery
- A minimum of 1 year follow-up
- Written consent
Key exclusion criteria (2 listed)
- Age <18
- No limb-salvage surgery due to sarcoma
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 |
|---|---|---|
| Limb salvage | Procedure or surgery | – |
Primary outcome
Validity of the lower-limb Musculoskeletal Tumor Society score and the Toronto Extremity Salvage Score
Time frame: two to five years
The validity is studied
Reliability of the lower-limb Musculoskeletal Tumor Society score and the Toronto Extremity Salvage Score
Time frame: two to five years
The test-retest reliability is studied
Health-related quality of life after limb salvage
Time frame: two to five years
Assessment of health-related quality of life
Assessment of the functional ability after limb salvage
Time frame: two to five years
Assessment of functional ability
4 secondary outcomes
Quality of Life Questionnaire-Core 30
Time frame: two to five years
The 15-dimensions health-related quality of life instrument
Time frame: two to five years
The Musculoskeletal Tumor Society score lower extremity section
Time frame: two to five years
The Toronto Extremity Salvage Score lower extremity section
Time frame: two to five years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
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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.
Erkki J Tukiainen, MD, PhD study director
Helsinki University Hospital and University of Helsinki
Carl Blomqvist, MD, PhD study director
Helsinki University Hospital and University of Helsinki
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 Limb Salvage, run by Helsinki University Central Hospital at 1 site in Finland.
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 6 inclusion and 2 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: finished, as of the sponsor's last update on 19 Jan 2021. 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 Finland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity of the lower-limb Musculoskeletal Tumor Society score and the Toronto Extremity Salvage Score (time frame: two to five years). The study lists 4 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 Jan 2021.