Contact information
Type
Scientific
Primary contact
Dr Niels Ove Illum
ORCID ID
Contact details
Department of Paediatrics H
Odense University Hospital
Sdr Boulevard 29
Odense C
5000
Denmark
+45 22 83 91 02
niels.illum@ouh.regionsyddanmark.dk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
01
Study information
Scientific title
Clinical symptoms and time to diagnosis in a cohort of Southern Danish children with brain tumours: a retrospective observational cohort study
Acronym
Study hypothesis
To identify time to diagnosis and first symptoms in children with brain tumours in order to improve coming diagnostic processes.
Ethics approval
No specific ethical requirements for this study according to Danish National Committee on Biomedical Research Ethics, as the study was observational and non-randomised only. Parent to every single participating child gave written consent.
Study design
Retrospective observational cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Condition
Brain tumour
Intervention
All children living in Southern Denmark that had a brain tumour in the period from 01/10/1994 to 31/12/1999 were identified at the referral Hospital record system. Letters were forwarded to all parents, written agreement obtained and telephone interviews undertaken. Data were analysed by comparing pre-diagnosis symptoms with time from parents first encounters to diagnosis. No successive data obtained.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Clinical signs and pre-diagnosis symptomatic interval. Analyses were performed in 2010 with close August 2010.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/01/1999
Overall trial end date
31/12/1999
Reason abandoned
Eligibility
Participant inclusion criteria
Retrospective study using patient records. Records of all children living in Southern Danish Region with brain tumours, from 1994 to 1999, were investigated.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
50
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/01/1999
Recruitment end date
31/12/1999
Locations
Countries of recruitment
Denmark
Trial participating centre
Department of Paediatrics H
Odense C
5000
Denmark
Sponsor information
Organisation
Odense University Hospital (Denmark)
Sponsor details
Department of Pediatrics
Sdr Boulevard 29
Odense C
5000
Denmark
+45 65 41 15 47
arne.hoest@ouh.regionsyddanmark.dk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
University/education
Funder name
No formal funding, incidental costs covered by following institutions:
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Southern Danish University (Denmark) - Faculty of Medicine
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Odense University Hospital (Denmark) - Department of Pediatrics
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21722538
Publication citations
-
Results
Klitbo DM, Nielsen R, Illum NO, Wehner PS, Carlsen N, Symptoms and time to diagnosis in children with brain tumours., Dan Med Bull, 2011, 58, 7, A4285.