Welcome
Support Centre
21 October 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
A study of computed tomography (CT) scan frequency in patients with stage I testicular teratoma
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
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.