NCT03077178

Brief Summary

In order to describe functional impact of surgery in elderly patients treated for lower-limb soft-tissue sarcoma, the investigators set up this project which aims to identify prognostic factors among geriatric and functional assessment.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

February 20, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 10, 2017

Completed
9 months until next milestone

Study Start

First participant enrolled

November 30, 2017

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2023

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

5.1 years

First QC Date

February 20, 2017

Last Update Submit

January 28, 2026

Conditions

Soft Tissue Sarcoma Adult

Keywords

Soft Tissue SarcomaSurgeryFunctional ImpactElderly PatientGeriatrics

Outcome Measures

Primary Outcomes (1)

  • Change in Physical functioning assessment

    Quality of life questionnaire QLQ-C30

    Change from baseline until 36 months after surgery

Secondary Outcomes (7)

  • Functional status assessment (TESS)

    Change from baseline until 36 months after surgery

  • Functional status assessment (MST)

    Change from baseline until 36 months after surgery

  • Quality of life assessment QLQ-C30

    Change from baseline until 36 months after surgery

  • Quality of life assessment QLQ-EDL-14

    Change from baseline until 36 months after surgery

  • Geriatric parameters assessment - G8

    baseline

  • +2 more secondary outcomes

Study Arms (1)

Prospective cohort

EXPERIMENTAL

Geriatric assessment

Procedure: Geriatric assessment

Interventions

Geriatric assessmentPROCEDURE

Geriatric assessment, questionnaire assessment

Prospective cohort

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Aged more than 70 years,
  • Soft tissue sarcoma histologically proven,
  • Sarcoma of the soft tissues of the lower limbs,
  • Operable disease (first-line treatment or neo-adjuvant therapy),
  • ECOG, Performance Status ≤ 2,
  • Decision of surgery validated in Multidisciplinary Consultation Meeting,
  • Reports of the non-opposition documented in the patient file before any procedure specific to the study,
  • Affiliation to system of Social Security (accordance with article L1121-11 of the Code of Public Health).

You may not qualify if:

  • Metastatic disease from the onset or relapse
  • Participation in another study involving a similar geriatric assessment.
  • Geographic, familial, social, psychological or psychiatric factors that make the patient incapable of undergoing the study's follow-up and procedures.
  • Persons deprived of liberty or placed under judicial protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Bergonié

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Sarcoma

Interventions

Geriatric Assessment

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth StatusDemographyPopulation CharacteristicsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2017

First Posted

March 10, 2017

Study Start

November 30, 2017

Primary Completion

January 15, 2023

Study Completion

March 1, 2026

Last Updated

January 30, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)