Clinical symptoms and time to diagnosis in a cohort of Southern Danish children with brain tumours

ISRCTN	ISRCTN88306789
DOI	https://doi.org/10.1186/ISRCTN88306789
Protocol serial number	01
Sponsor	Odense University Hospital (Denmark)
Funders	No formal funding, incidental costs covered by following institutions:, Southern Danish University (Denmark) - Faculty of Medicine, Odense University Hospital (Denmark) - Department of Pediatrics

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Niels Ove Illum
Scientific

Department of Paediatrics H
Odense University Hospital
Sdr Boulevard 29
Odense C
5000
Denmark

Phone	+45 22 83 91 02
Email	niels.illum@ouh.regionsyddanmark.dk

Primary study design	Observational
Study design	Retrospective observational cohort study
Secondary study design	Cohort study
Scientific title	Clinical symptoms and time to diagnosis in a cohort of Southern Danish children with brain tumours: a retrospective observational cohort study
Study objectives	To identify time to diagnosis and first symptoms in children with brain tumours in order to improve coming diagnostic processes.
Ethics approval(s)	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.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Clinical signs and pre-diagnosis symptomatic interval. Analyses were performed in 2010 with close August 2010.
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	31/12/1999

Participant type(s)	Patient
Age group	Child
Sex	All
Target sample size at registration	50
Key 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.
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/01/1999
Date of final enrolment	31/12/1999

Department of Paediatrics H

Odense C
5000
Denmark

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2011		Yes	No