MRC Study of carcinoma in situ of the contralateral testis

ISRCTN	ISRCTN37957513
DOI	https://doi.org/10.1186/ISRCTN37957513
Protocol serial number	TE11
Sponsor	Medical Research Council (MRC) (UK)
Funder	Medical Research Council (MRC) (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mrs Pat Cook
Scientific

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

Email	pat.cook@ctu.mrc.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To ascertain the prevalence of CIS of testis in this group of patients.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cancer
Intervention	All subjects biopsied. Positive biopsy: optional randomisation between radiotherapy or surveillance. Negative biospy: surveillance.
Intervention type	Other
Primary outcome measure(s)	Determine prevalence of CIS and the development of invasive tumour.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/1995

Participant type(s)	Patient
Age group	Not Specified
Sex	Male
Target sample size at registration	208
Key inclusion criteria	1. Germ cell tumour of testis or history of one having been excised in the previous five years 2. History of maldescent 3. Volume of 12 ml or less in remaining testis
Key exclusion criteria	Previous chemotherapy
Date of first enrolment	01/01/1989
Date of final enrolment	31/12/1995

MRC Clinical Trials Unit

London
NW1 2DA
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/1998		Yes	No