A study of computed tomography (CT) scan frequency in patients with stage I testicular teratoma
| ISRCTN | ISRCTN56475197 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56475197 |
| ClinicalTrials.gov (NCT) | NCT00003420 |
| Protocol serial number | TE08 |
| Sponsor | Medical Research Council (MRC) (UK) |
| Funder | Medical Research Council (UK) |
- Submission date
- 06/04/2000
- Registration date
- 06/04/2000
- Last edited
- 28/10/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Miss Sharon Naylor
Scientific
Scientific
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
| not@provided.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | A study of computed tomography (CT) scan frequency in patients with stage I testicular teratoma |
| Study objectives | 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. |
| Ethics approval(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | Cancer |
| Intervention | 1. One group receives two CT scans 2. The other group receives five CT scans |
| Intervention type | Other |
| Primary outcome measure(s) |
Stage of the disease at relapse (IGCC Classification), time from entry to detection of relapse. |
| Key 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 |
| Completion date | 30/04/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Male |
| Target sample size at registration | 900 |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/12/1997 |
| Date of final enrolment | 30/04/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 10/04/2007 | Yes | No | |
| Plain English results | 28/10/2021 | No | Yes | ||
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
28/10/2021: Cancer Research UK plain English results link added.
