Condition category
Cancer
Date applied
09/11/2010
Date assigned
12/11/2010
Last edited
21/12/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.ouh.dk/wm122110

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

  1. 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.

Additional files

Editorial Notes