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Outcomes in Lower Extremity Soft Tissue Sarcoma Patients After Limb Salvage

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ClinicalTrials.gov Identifier: NCT02536053
Recruitment Status : Recruiting
First Posted : August 31, 2015
Last Update Posted : August 19, 2016
Sponsor:
Information provided by (Responsible Party):
Jussi Repo, Helsinki University Central Hospital

Brief 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.

Condition or disease Intervention/treatment
Limb Salvage Procedure: Limb salvage

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 Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Functional Outcomes and Health Related Quality of Life in Lower Extremity Soft Tissue Sarcoma Patients After Limb Salvage: A Prospective Study
Study Start Date : December 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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

  2. 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

  3. Health-related quality of life after limb salvage [ Time Frame: two to five years ]
    Assessment of health-related quality of life

  4. Assessment of the functional ability after limb salvage [ Time Frame: two to five years ]
    Assessment of functional ability


Secondary Outcome Measures :
  1. Quality of Life Questionnaire-Core 30 [ Time Frame: two to five years ]
    Health-related quality of life assessment

  2. The 15-dimensions health-related quality of life instrument [ Time Frame: two to five years ]
    Health-related quality of life assessment

  3. The Musculoskeletal Tumor Society score lower extremity section [ Time Frame: two to five years ]
    Functional assessment of the reconstructed limb

  4. The Toronto Extremity Salvage Score lower extremity section [ Time Frame: two to five years ]
    Functional assessment of the reconstructed limb



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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Lower extremity sarcoma patient who underwent limb-salvage surgery
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Age <18
  • No limb-salvage surgery due to sarcoma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02536053


Contacts
Contact: Gilber Kask, MD gilber.kask@gmail.com
Contact: Ian Barner-Rasmussen, MD, PhD ian.barner-rasmussen@hus.fi

Locations
Finland
Cancer center, Helsinki University Hospital and University of Helsinki Recruiting
Helsinki, Helsinki and Uusimaa, Finland, 00029
Contact: Jussi Repo, MD    +358443593100    mrjussirepo@gmail.com   
Contact: Ian Barner-Rasmussen, MD, PhD         
Principal Investigator: Gilber Kask, M, MBA         
Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
Study Director: Erkki J Tukiainen, MD, PhD Helsinki University Hospital and University of Helsinki
Study Director: Carl Blomqvist, MD, PhD Helsinki University Hospital and University of Helsinki

Responsible Party: Jussi Repo, MD, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT02536053     History of Changes
Other Study ID Numbers: 324/13/03/02/2014/2
First Posted: August 31, 2015    Key Record Dates
Last Update Posted: August 19, 2016
Last Verified: August 2016

Keywords provided by Jussi Repo, Helsinki University Central Hospital:
[E04.100.814.603]

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms