| Source of record | UK Trials |
| ISRCTN | ISRCTN56475197 |
| Date ISRCTN assigned | 06/04/2000 |
| Local reference number(s) | TE08 |
| Public title | A study of computed tomography (CT) scan frequency in patients with stage I testicular teratoma |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Cancer |
| 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration.
|
| Countries of trial | United Kingdom |
| 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 |
| Patient information material |
|
| Anticipated start date | 01/12/1997 |
| Anticipated end date | 30/04/2003 |
| Status of trial | Completed |
| 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 |
| 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 |
| Sources of funding | Medical Research Council (UK) |
| Sponsor name | Medical Research Council (UK) |
| Sponsor details | 20 Park Crescent
London
United Kingdom
W1B 1AL |
| Sponsor telephone | +44 (0)20 7636 5422 |
| Sponsor fax | +44 (0)20 7436 6179 |
| Sponsor email | clinical.trial@headoffice.mrc.ac.uk |
| Sponsor website | http://www.mrc.ac.uk |
| Contact name | Miss Sharon Naylor |
| Contact details | MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN56475197 |
| Date last extracted from ISRCTN register | 17/04/2008 |
