NCT02309242

Brief Summary

The aim of the proposed project is to study the long-term impact of adjuvant systemic multi- agent chemotherapy (cisplatin, anthracyclines, vincristine, methotrexate, alkylating agents) in survivors (treated between 1992 and 2014 in UZ Leuven) of paediatric bone or soft tissue sarcomas on neurocognitive functioning.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

October 24, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2014

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

August 21, 2015

Status Verified

August 1, 2015

Enrollment Period

3.8 years

First QC Date

October 24, 2014

Last Update Submit

August 20, 2015

Conditions

Sarcoma, Soft TissueOsteosarcoma Tumor

Outcome Measures

Primary Outcomes (1)

  • Neuropsychological functioning

    4 years

Study Arms (1)

Neuropsychological assessment, MRI

NO INTERVENTION

This is a cross-sectional mono-center study examining survivors who were exposed to chemotherapy for bone or soft tissue sarcomas in childhood. Survivors of bone or soft tissue sarcomas will be examined with neuropsychological tests, questionnaires and advanced MR imaging (Neuropsychological assessment, MRI). Results will be compared to a healthy control group matched for age and sex.

Behavioral: Neuropsychological assessment, MRI

Interventions

Neuropsychological assessment, MRIBEHAVIORAL

All subjects will be imaged (MRI) on the same 3T Philips scanner with a 32-channel phased-array head coil, located in the radiology department at UZ Leuven. For the neuropsychological assessment we will implement an extended neuropsychological assessment battery: ANT, CMS, Rey, BRIEF, WISC III, PedsQL, STAI, BDi, achenbach questionnaires

Neuropsychological assessment, MRI

Eligibility Criteria

Age7 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Survivors of paediatric bone or soft tissue sarcomas, who were treated from 1992 onwards in the paediatric haematooncology department of UZLeuven according to one of the following treatment protocols.
  • \*For soft tissue sarcomas: MMT 95, MMT 98, RMS2005 or NRST2005
  • \*For Ewing sarcoma: EICESS 92, Euro-Ewing 99 or Euro-Ewing 2008
  • \*For osteosarcoma: EORTC 80931 or Euramos1 protocols
  • There will be variability in treatment regimens, but the patient group will be clustered into four subgroups:
  • Cisplatin and anthracyclines
  • Cisplatin, anthracyclines and methotrexate
  • Alkylating agents
  • Alkylating agents and anthracyclines

You may not qualify if:

  • Mental retardation documented before treatment
  • Inability to perform the tests because of motor or sensory deficits
  • Epilepsy
  • Other cognitive disorders
  • Depression
  • Relapse
  • Parameningeal or intracranial sarcomas
  • Syndrome (e.g. Down)
  • Autologous stemcell transplantation
  • Head/neck/spinal radiotherapy or psychopharmaca

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven , pediatric oncology

Leuven, Vl Brabant, 3000, Belgium

RECRUITING

MeSH Terms

Conditions

SarcomaOsteosarcoma

Interventions

Neuropsychological TestsMagnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Bone TissueNeoplasms, Connective Tissue

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and ActivitiesSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Anne Uyttebroeck, MD, PhD

    UZ Leuven

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne Uyttebroeck, MD, PhD

CONTACT

+32 16 3439anne.uyttebroeck@uzleuven.be

Charlotte Sleurs, master

CONTACT

+32 16 3406charlotte.sleurs@kuleuven.be

Study Design

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

Study Record Dates

First Submitted

October 24, 2014

First Posted

December 5, 2014

Study Start

December 1, 2014

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

August 21, 2015

Record last verified: 2015-08

Locations

BE(1)