NCT02536053

Brief Summary

This study aims to:

  1. 1.validate the Finnish version of the Musculoskeletal Tumor Society scale and the Toronto Extremity Salvage Score lower extremity sections and to
  2. 2.assess the functional ability and health-related quality of life (HRQoL) of lower extremity sarcoma patients who have undergone limb salvage surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
141

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 31, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2020

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2020

Completed
Last Updated

January 19, 2021

Status Verified

January 1, 2021

Enrollment Period

4.1 years

First QC Date

August 18, 2015

Last Update Submit

January 15, 2021

Conditions

Limb Salvage

Keywords

[E04.100.814.603]

Outcome Measures

Primary Outcomes (4)

  • Validity of the lower-limb Musculoskeletal Tumor Society score and the Toronto Extremity Salvage Score

    The validity is studied

    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

    two to five years

  • Health-related quality of life after limb salvage

    Assessment of health-related quality of life

    two to five years

  • Assessment of the functional ability after limb salvage

    Assessment of functional ability

    two to five years

Secondary Outcomes (4)

  • Quality of Life Questionnaire-Core 30

    two to five years

  • The 15-dimensions health-related quality of life instrument

    two to five years

  • The Musculoskeletal Tumor Society score lower extremity section

    two to five years

  • The Toronto Extremity Salvage Score lower extremity section

    two to five years

Interventions

Limb salvagePROCEDURE

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Lower extremity sarcoma patient who underwent limb-salvage surgery

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer center, Helsinki University Hospital and University of Helsinki

Helsinki, Helsinki and Uusimaa, 00029, Finland

Location

MeSH Terms

Interventions

Limb Salvage

Intervention Hierarchy (Ancestors)

Vascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeOrthopedic ProceduresPlastic Surgery Procedures

Study Officials

  • 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

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 18, 2015

First Posted

August 31, 2015

Study Start

December 1, 2015

Primary Completion

January 10, 2020

Study Completion

January 15, 2020

Last Updated

January 19, 2021

Record last verified: 2021-01

Locations

FI(1)