|
ISRCTN
|
ISRCTN56475197
|
|
DOI
|
10.1186/ISRCTN56475197
|
|
ClinicalTrials.gov identifier
|
NCT00003420
|
|
EudraCT number
|
|
|
Public title
|
A study of computed tomography (CT) scan frequency in patients with stage I testicular teratoma
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
TE08
|
|
Study hypothesis
|
To assess the value of frequent abdominal and chest CT scans in the follow-up of patients with stage I non-seminomatous germ cell tumours (NSGCT) who are on a surveillance programme. After baseline scans confirming stage I disease, patients will be randomised between two and five further CT scans during their follow up, with the nature and frequency of all other investigations remaining constant.
|
|
Lay summary
|
|
|
Ethics approval
|
Not provided at time of registration.
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Cancer
|
|
Participants - inclusion criteria
|
1. Histologically confirmed stage I non-seminomatous germ cell tumour of the testis
2. Patients must be able to attend for regular surveillance
3. The interval between orchidectomy and randomisation should not exceed 8 weeks
4. No co-existent or previously treated malignant disease, except successfully treated non-melanotic skin cancer
|
|
Participants - exclusion criteria
|
Not provided at time of registration
|
|
Anticipated start date
|
01/12/1997
|
|
Anticipated end date
|
30/04/2003
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
900
|
|
Interventions
|
1. One group receives two CT scans
2. The other group receives five CT scans
|
|
Primary outcome measure(s)
|
Stage of the disease at relapse (IGCC Classification), time from entry to detection of relapse.
|
|
Secondary outcome measure(s)
|
Overall survival, identification of the first investigation or sign prompting diagnosis of relapse, incidence of second malignancies and balance of costs of treatment determined through health economics study
|
|
Sources of funding
|
Medical Research Council (UK)
|
|
Trial website
|
http://www.ctu.mrc.ac.uk/studies/TE08.asp
|
|
Publications
|
Results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=17416851
|
|
Contact name
|
Miss
Sharon
Naylor
|
|
Address
|
MRC Clinical Trials Unit
222 Euston Road
|
|
City/town
|
London
|
|
Zip/Postcode
|
NW1 2DA
|
|
Country
|
United Kingdom
|
|
Email
|
|
|
Sponsor
|
Medical Research Council (MRC) (UK)
|
|
Address
|
20 Park Crescent
|
|
City/town
|
London
|
|
Zip/Postcode
|
W1B 1AL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7636 5422
|
|
Fax
|
+44 (0)20 7436 6179
|
|
Email
|
clinical.trial@headoffice.mrc.ac.uk
|
|
Sponsor website:
|
http://www.mrc.ac.uk
|
|
Date applied
|
06/04/2000
|
|
Last edited
|
14/09/2007
|
|
Date ISRCTN assigned
|
06/04/2000
|
