Functional Outcomes and HRQoL in Upper-extremity Sarcoma... | NCT02380651

Studies
Functional Outcomes and HRQoL in Upper-extremity Sarcoma Patients After Limb Salvage

NCT02380651

Sponsor

Helsinki University Central Hospital

Status

Completed

Last Update Posted

Jan 19, 2021Actual

Enrollment

55Actual

Phase

Not provided

Conditions

Cancer of Muscle

Interventions

Limb salvage

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2015

Primary Completion Date

Sep 2018Actual

Completion Date

Sep 2018Actual

First Submitted Date

Mar 1, 2015

First Submission Date that Met QC Criteria

Mar 1, 2015

First Posted Date

Mar 5, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 15, 2021

Last Update Posted Date

Jan 19, 2021Actual

Name	Class
Tampere University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

55Actual

Name	Type	Description	Arm Group Labels	Other Names
Limb salvage	Procedure	Local or free flaps

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Sarcoma recurrence	to assess sarcoma recurrence	6 months to five years
Quality of Life Questionnaire-Core 30	to assess the health-related quality of life

Other Outcomes

Measure	Description	Time Frame
Visual Analogue Scale for pain	to assess pain	6 months to five years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Upper extremity sarcoma patient who underwent limb-salvage surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Erkki J Tukiainen, MD, PhD	Helsinki University Central Hospital	Study Director
Carl Blomqvist, MD, PhD	Helsinki University Central Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Helsinki University Central Hospital		Helsinki	Uusimaa	00029	Finland
Tampere University Hospital

Condition Browse Module

MeSH Terms

ID	Term
D019042	Muscle Neoplasms

Ancestor Terms

ID	Term
D012983	Soft Tissue Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D009135	Muscular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D023821	Limb Salvage

Ancestor Terms

ID	Term
D014656	Vascular Surgical Procedures
D013504	Cardiovascular Surgical Procedures
D013514	Surgical Procedures, Operative
D019637	Orthopedic Procedures

Browse Leaves

Not provided

Browse Branches

Not provided