Children With a CraniopharyngiomaCRANIONCT03139526
Social Participation After Childhood Craniopharyngioma
An observational study of Children With a Craniopharyngioma, run by BERTHILLIER Julien.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Children With a Craniopharyngioma
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 1 Jul 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients hospitalized in the pediatric neurosurgery department of Hospices Civils de Lyon between 2007 and 2013
Who may be able to join
- Children with a craniopharyngioma
Who cannot join
- None
About this study
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.
- Conditions
- Children With a Craniopharyngioma
- Being tested
- observational study so no intervention
- Keywords
- Craniopharyngioma, Children, Social participation, Life-H questionnaire
- Medical subject headings
- Craniopharyngioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational study so no interventionOther
observational study, so no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At maximum 6 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start1 Jan 2014
- Primary completion1 Jul 2014
- Study completion1 Jul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children With a CraniopharyngiomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- BERTHILLIER Julien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, BERTHILLIER Julien, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03139526
- Sponsor's protocol ID
- 2015-018
- Acronym
- CRANIO
- Status last verified
- May 2017
- First submitted
- 2 May 2017
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Participation After Childhood Craniopharyngioma
- ClinicalTrials.gov ID
- NCT03139526
- Acronym / sponsor ID
- CRANIO / 2015-018
- Conditions
- Children With a Craniopharyngioma
- Keywords
- Craniopharyngioma, Children, Social participation, Life-H questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- BERTHILLIER JulienUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Jul 2014 (actual)
- Study completion
- 1 Jul 2014 (actual)
- First posted
- 4 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients hospitalized in the pediatric neurosurgery department of Hospices Civils de Lyon between 2007 and 2013
Key inclusion criteria (1 listed)
- Children with a craniopharyngioma
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational study so no interventionobservational study, so no intervention | Other | – |
Primary outcome
LIFE-H questionnaire (Assessment of Life Habits)
Time frame: At maximum 6 months after inclusion
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Children With a Craniopharyngioma, run by BERTHILLIER Julien.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LIFE-H questionnaire (Assessment of Life Habits) (time frame: At maximum 6 months after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2017.