NCT02380651

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2015

Typical duration for all trials

Geographic Reach
1 country

2 active sites

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

March 1, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2015

Completed
9 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

January 19, 2021

Status Verified

January 1, 2021

Enrollment Period

2.8 years

First QC Date

March 1, 2015

Last Update Submit

January 15, 2021

Conditions

Cancer of Muscle

Outcome Measures

Primary Outcomes (1)

  • Health-related quality of life and upper-extremity functional capability

    To assess health-related quality of life and upper-extremity functional capability

    6 months to five years

Secondary Outcomes (6)

  • Sarcoma recurrence

    6 months to five years

  • Quality of Life Questionnaire-Core 30

    6 months to five years

  • the 15D health-related quality of life instrument

    6 months to five years

  • The QuickDASH

    6 months to five years

  • The MSTS upper extremity section

    6 months to five years

  • +1 more secondary outcomes

Other Outcomes (1)

  • Visual Analogue Scale for pain

    6 months to five years

Interventions

Limb salvagePROCEDURE

Local or free flaps

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Upper extremity sarcoma patient who underwent limb-salvage surgery

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Helsinki University Central Hospital

Helsinki, Uusimaa, 00029, Finland

Location

Tampere University Hospital

Tampere, Finland

Location

MeSH Terms

Conditions

Muscle Neoplasms

Interventions

Limb Salvage

Condition Hierarchy (Ancestors)

Soft Tissue NeoplasmsNeoplasms by SiteNeoplasmsMuscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Vascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeOrthopedic ProceduresPlastic Surgery Procedures

Study Officials

  • Erkki J Tukiainen, MD, PhD

    Helsinki University Central Hospital

    STUDY DIRECTOR

  • Carl Blomqvist, MD, PhD

    Helsinki University Central Hospital

    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

March 1, 2015

First Posted

March 5, 2015

Study Start

December 1, 2015

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

January 19, 2021

Record last verified: 2021-01

Locations

FI(2)