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 number	NCT00003420
Secondary identifying numbers	TE08

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Miss Sharon Naylor
Scientific

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Email	not@provided.com

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
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	Stage of the disease at relapse (IGCC Classification), time from entry to detection of relapse.
Secondary outcome measures	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
Overall study start date	01/12/1997
Completion date	30/04/2003

Participant type(s)	Patient
Age group	Not Specified
Sex	Male
Target number of participants	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

MRC Clinical Trials Unit

London
NW1 2DA
United Kingdom

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone	+44 (0)20 7636 5422
Email	clinical.trial@headoffice.mrc.ac.uk
Website	http://www.mrc.ac.uk

Research council

Medical Research Council (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

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

28/10/2021: Cancer Research UK plain English results link added.