Brain TumourNCT00996450
Educational Follow-up in a Cohort of Children at the Royal Marsden Hospital (RMH)
An observational study of Brain Tumour, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
To document pre-diagnosis educational abilities, to document any change in educational achievements following treatment, to document educational support given within the statement process and to document the timing of support. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Brain Tumour
- How many people
- 110 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2008to Dec 2009
- 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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Cases will be identified by looking at RMH coding database. Medical information will be sort from the electronic patient records (EPR) and from the patient notes.
Who may be able to join
- patients/parental consent for RMH accessing educational information from them and their school
- patients with a primary brain tumour
Who cannot join
- children with secondary brain tumours
- children who have had treatment for a relapse of primary brain tumour
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal Marsden NHS Foundation Trust
Belmont, Surrey, SM2 5PT
About this study
Official title: Educational Follow-up in a Cohort of Children at the Royal Marsden Hospital, Following the Treatment of a Brain Tumour
To document pre-diagnosis educational abilities, to document any change in educational achievements following treatment, to document educational support given within the statement process and to document the timing of support.
Read the detailed description
This will be a retrospective study. Cases will be identified by looking at the Royal Marsden Hospital (RMH) coding database. All the patients will have completed treatment for a brain tumour. The children all need to have started school before the diagnosis of their brain tumour so that we can look at easily defined educational assessments in this cohort. Children will be identified by looking at RMH coding of diagnosis and include children aged between 4 years and 18 years old (school age).
- Conditions
- Brain Tumour
- Keywords
- brain tumour
- Medical subject headings
- Brain Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2009 (estimated)
- Study startJun 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumourStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- 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
- Family based
- Time perspective
- Retrospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Darren Hargrave, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00996450
- Sponsor's protocol ID
- CCR2903
- Status last verified
- Oct 2009
- First submitted
- 15 Oct 2009
- Last updated
- 23 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Educational Follow-up in a Cohort of Children at the Royal Marsden Hospital, Following the Treatment of a Brain Tumour
- ClinicalTrials.gov ID
- NCT00996450
- Acronym / sponsor ID
- CCR2903
- Conditions
- Brain Tumour
- Keywords
- brain tumour
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 16 Oct 2009 (estimated)
- 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.
To document pre-diagnosis educational abilities, to document any change in educational achievements following treatment, to document educational support given within the statement process and to document the timing of support.
Detailed description
This will be a retrospective study. Cases will be identified by looking at the Royal Marsden Hospital (RMH) coding database. All the patients will have completed treatment for a brain tumour. The children all need to have started school before the diagnosis of their brain tumour so that we can look at easily defined educational assessments in this cohort. Children will be identified by looking at RMH coding of diagnosis and include children aged between 4 years and 18 years old (school age).
Study design
- Observational model
- Family based
- Time perspective
- Retrospective
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Cases will be identified by looking at RMH coding database. Medical information will be sort from the electronic patient records (EPR) and from the patient notes.
Key inclusion criteria (2 listed)
- patients/parental consent for RMH accessing educational information from them and their school
- patients with a primary brain tumour
Key exclusion criteria (2 listed)
- children with secondary brain tumours
- children who have had treatment for a relapse of primary brain tumour
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
2 secondary outcomes
To compare educational achievements of children of different tumour types following treatment.
To document if there are any differences in educational achievements depending on the age at diagnosis of the brain tumour.
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 23 May 2016.
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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.
Dr Darren Hargrave principal investigator
Royal Marsden NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Tumour, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
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 2 inclusion and 2 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 23 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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 23 May 2016.