Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Educational Follow-up in a Cohort of Children at the Royal Marsden Hospital (RMH)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00996450
First received: October 15, 2009
Last updated: May 20, 2016
Last verified: October 2009
  Purpose
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.

Condition
Brain Tumour

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Retrospective
Official Title: Educational Follow-up in a Cohort of Children at the Royal Marsden Hospital, Following the Treatment of a Brain Tumour

Resource links provided by NLM:


Further study details as provided by Royal Marsden NHS Foundation Trust:

Secondary Outcome Measures:
  • To compare educational achievements of children of different tumour types following treatment. [ Designated as safety issue: No ]
  • To document if there are any differences in educational achievements depending on the age at diagnosis of the brain tumour. [ Designated as safety issue: No ]

Estimated Enrollment: 110
Study Start Date: June 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
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).
  Eligibility

Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • patients/parental consent for RMH accessing educational information from them and their school
  • patients with a primary brain tumour

Exclusion Criteria:

  • children with secondary brain tumours
  • children who have had treatment for a relapse of primary brain tumour
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00996450

Locations
United Kingdom
The Royal Marsden NHS Foundation Trust
Belmont, Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
Principal Investigator: Dr Darren Hargrave Royal Marsden NHS Foundation Trust
  More Information

Responsible Party: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00996450     History of Changes
Other Study ID Numbers: CCR2903 
Study First Received: October 15, 2009
Last Updated: May 20, 2016
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Royal Marsden NHS Foundation Trust:
brain tumour

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 23, 2016