Cancer of MuscleNCT02380651
Functional Outcomes and HRQoL in Upper-extremity Sarcoma Patients After Limb Salvage
An observational study of Cancer of Muscle, run by Helsinki University Central Hospital at 2 sites in Finland.
Trial summary
This study aims to assess the functional ability and health-related quality of life (HRQoL) of upper extremity sarcoma patients who have undergone limb salvage surgery. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cancer of Muscle
- What is being tested?
- Limb salvage
- Type of treatment
- Surgery or procedure
- How many people
- 55 participants
- Where
- 2 sitesFinland
- Study dates
- Dec 2015to Sep 2018
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Upper extremity sarcoma patient who underwent limb-salvage surgery
Who may be able to join
- Upper extremity soft tissue sarcoma locating in between scapula to arm
- No metastasis at the time of diagnosis
- Undergone limb salvage surgery
- A minimum of 6 months follow-up
- Written consent
- Age > 18
Who cannot join
- Age <18
- No limb-salvage surgery due to sarcoma
- Deceased
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Helsinki University Central Hospital
Helsinki, Uusimaa, 00029
Tampere University Hospital
Tampere
About this study
Official title: Functional Outcomes and Health Related Quality of Life in Upper-extremity Sarcoma Patients After Limb Salvage: a Prospective Study
This study aims to assess the functional ability and health-related quality of life (HRQoL) of upper extremity sarcoma patients who have undergone limb salvage surgery.
Read the detailed description
The purpose of this study is to assess the functional capabilities and health-related quality of life (HRQoL) of upper-extremity sarcoma patients who have undergone limb salvage surgery.
Patient hospital records are retrospectively reviewed for demographic and clinical data.
The patient recruitment takes place at the outpatient clinic of the Comprehensive Cancer Center, Helsinki University Hospital, and Tampere University Hospital. The study includes a cross-sectional assessment at six months follow-up with five validated questionnaires. A follow-up is conducted two and five years after surgery in the outpatient clinic.
- Conditions
- Cancer of Muscle
- Being tested
- Limb salvage
- Medical subject headings
- Muscle Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Limb salvageProcedure or surgery
Local or free flaps
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life and upper-extremity functional capability
To assess health-related quality of life and upper-extremity functional capability
Measured: 6 months to five years
Secondary outcomes (6)
Sarcoma recurrence
to assess sarcoma recurrence
Measured: 6 months to five years
Quality of Life Questionnaire-Core 30
to assess the health-related quality of life
Measured: 6 months to five years
the 15D health-related quality of life instrument
to assess the health-related quality of life
Measured: 6 months to five years
The QuickDASH
to assess the upper-extremity function
Measured: 6 months to five years
The MSTS upper extremity section
to assess the upper-extremity function
Measured: 6 months to five years
The TESS upper extremity section
to assess the upper-extremity function
Measured: 6 months 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 posted5 Mar 2015 (estimated)
- Study startDec 2015
- Primary completionSep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of MuscleStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University Hospital
- Responsible party
- Principal investigator, Jussi Repo, Helsinki University Central Hospital
- Investigators
- Erkki J Tukiainen, MD, PhD, Study director, Helsinki University Central HospitalCarl Blomqvist, MD, PhD, Study director, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02380651
- Sponsor's protocol ID
- 324/13/03/02/2014/1
- Status last verified
- Jan 2021
- First submitted
- 1 Mar 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 Upper-extremity Sarcoma Patients After Limb Salvage: a Prospective Study
- ClinicalTrials.gov ID
- NCT02380651
- Acronym / sponsor ID
- 324/13/03/02/2014/1
- Conditions
- Cancer of Muscle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- Tampere University Hospital
- Study start
- Dec 2015
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 5 Mar 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 assess the functional ability and health-related quality of life (HRQoL) of upper extremity sarcoma patients who have undergone limb salvage surgery.
Detailed description
The purpose of this study is to assess the functional capabilities and health-related quality of life (HRQoL) of upper-extremity sarcoma patients who have undergone limb salvage surgery.
Patient hospital records are retrospectively reviewed for demographic and clinical data.
The patient recruitment takes place at the outpatient clinic of the Comprehensive Cancer Center, Helsinki University Hospital, and Tampere University Hospital. The study includes a cross-sectional assessment at six months follow-up with five validated questionnaires. A follow-up is conducted two and five years after surgery in the outpatient clinic.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Upper extremity sarcoma patient who underwent limb-salvage surgery
Key inclusion criteria (6 listed)
- Upper extremity soft tissue sarcoma locating in between scapula to arm
- No metastasis at the time of diagnosis
- Undergone limb salvage surgery
- A minimum of 6 months follow-up
- Written consent
Key exclusion criteria (3 listed)
- Age <18
- No limb-salvage surgery due to sarcoma
- Deceased
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 salvageLocal or free flaps | Procedure or surgery | – |
Primary outcome
Health-related quality of life and upper-extremity functional capability
Time frame: 6 months to five years
To assess health-related quality of life and upper-extremity functional capability
6 secondary outcomes
Sarcoma recurrence
Time frame: 6 months to five years
Quality of Life Questionnaire-Core 30
Time frame: 6 months to five years
the 15D health-related quality of life instrument
Time frame: 6 months to five years
The QuickDASH
Time frame: 6 months to five years
The MSTS upper extremity section
Time frame: 6 months to five years
The TESS upper extremity section
Time frame: 6 months 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 Central Hospital
Carl Blomqvist, MD, PhD study director
Helsinki University Central Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer of Muscle, run by Helsinki University Central Hospital at 2 sites 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 3 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 2 sites 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?
Health-related quality of life and upper-extremity functional capability (time frame: 6 months to five years). 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.