Condition category
Cancer
Date applied
08/02/2001
Date assigned
08/02/2001
Last edited
18/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

  1. 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.

Additional files

Editorial Notes