Social Participation After Childhood Craniopharyngioma | NCT03139526

Studies
Social Participation After Childhood Craniopharyngioma

NCT03139526

Sponsor

BERTHILLIER Julien

Status

Completed

Last Update Posted

May 8, 2017Actual

Enrollment

20Actual

Phase

Not provided

Conditions

Children With a Craniopharyngioma

Interventions

observational study so no intervention

Countries

Not provided

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

May 2017

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

Jan 1, 2014Actual

Primary Completion Date

Jul 1, 2014Actual

Completion Date

Jul 1, 2014Actual

First Submitted Date

May 2, 2017

First Submission Date that Met QC Criteria

May 2, 2017

First Posted Date

May 4, 2017Actual

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

May 3, 2017

Last Update Posted Date

May 8, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

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.

Detailed Description

Not provided

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

20Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
observational study so no intervention	Other	observational study, so no intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children with a craniopharyngioma

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003397	Craniopharyngioma

Ancestor Terms

ID	Term
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided