NCT03139526

Brief Summary

Craniopharyngioma is a rare, benign central nervous system tumor, which may be a source of multiple complications, from endocrinology to vision, neurology and neurocognitive functions. This morbidity can lead to reduced participation in life activities, as described in the International Classification of Functioning, Disability, and Health (ICF). The primary objective of this study is to measure participation in life activities in a population of children affected by childhood craniopharyngioma, using the assessement of life habits questionnaire (LIFE-H questionnaire), validated as a social participation measurement tool in various pediatric disabilities.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2014

Shorter than P25 for all trials

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

Study Start

First participant enrolled

January 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 4, 2017

Completed
Last Updated

May 8, 2017

Status Verified

May 1, 2017

Enrollment Period

6 months

First QC Date

May 2, 2017

Last Update Submit

May 3, 2017

Conditions

Children With a Craniopharyngioma

Keywords

CraniopharyngiomaChildrenSocial participationLife-H questionnaire

Outcome Measures

Primary Outcomes (1)

  • LIFE-H questionnaire (Assessment of Life Habits)

    The LIFE-H questionnaire is sent by mail to parents' patient. For parents who do not return the questionnaire completed, a telephone call is made and the LIFE-H questionnaire is completed by phone.

    At maximum 6 months after inclusion

Interventions

observational study so no interventionOTHER

observational study, so no intervention

Eligibility Criteria

Age1 Day - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients hospitalized in the pediatric neurosurgery department of Hospices Civils de Lyon between 2007 and 2013

You may qualify if:

  • Children with a craniopharyngioma

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Craniopharyngioma

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve Tissue

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Project Manager

Study Record Dates

First Submitted

May 2, 2017

First Posted

May 4, 2017

Study Start

January 1, 2014

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

May 8, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share