Contact information
Type
Scientific
Primary contact
Mrs Pat Cook
ORCID ID
Contact details
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
pat.cook@ctu.mrc.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
TE11
Study information
Scientific title
Acronym
Study hypothesis
To ascertain the prevalence of CIS of testis in this group of patients.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Cancer
Intervention
All subjects biopsied. Positive biopsy: optional randomisation between radiotherapy or surveillance. Negative biospy: surveillance.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Determine prevalence of CIS and the development of invasive tumour.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1989
Overall trial end date
31/12/1995
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Male
Target number of participants
208
Participant exclusion criteria
Previous chemotherapy
Recruitment start date
01/01/1989
Recruitment end date
31/12/1995
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1998 results in http://www.ncbi.nlm.nih.gov/pubmed/9751353
Publication citations
-
Results
Harland SJ, Cook PA, Fossa SD, Horwich A, Mead GM, Parkinson MC, Roberts JT, Stenning SP, Intratubular germ cell neoplasia of the contralateral testis in testicular cancer: defining a high risk group., J. Urol., 1998, 160, 4, 1353-1357.