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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ISRCTN
Last refreshed on:	13 January 2015
Main ID:	ISRCTN04011070
Date of registration:	12/09/2003
Prospective Registration:	No
Primary sponsor:	Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)
Public title:	Targeted screening for ovarian cancer in women over 50 years of age with vague presenting symptoms
Scientific title:
Date of first enrolment:	01/07/2002
Target sample size:	0
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN04011070
Study type:	Interventional
Study design:	Randomised controlled trial (Screening)
Phase:

Countries of recruitment
United Kingdom

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:	Usha Menon
Address:	Gynaecological Research Unit Charterhouse Square London EC1M 6GR London United Kingdom
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria: All general practices in East London and The City Health Authority (ELCHA) will be randomised to the study and control groups. We will follow up all ovarian cancers from both groups.
Exclusion criteria: Does not meet inclusion criteria

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Ovarian cancer
Cancer
Malignant neoplasm of ovary

Intervention(s)

All the general practices in the ELCHA region will be randomised. No contact will be made with the GPs randomised to the control group. Those practices randomised to the study group will be contacted to inform them about the study and invite their participation. GPs in this group will be asked to refer women, over 50 years of age and presenting with non-specific symptoms, and no obvious diagnosis, for a transvaginal ultrasound scan (TVS) and CA125 test. CA125 and TVS are considered the standard diagnostic tools for suspected ovarian cancer. Those women referred to the gynaecology cancer centre from the study group, and those referred in the usual way, with ovarian cancer, will be asked to fill in a questionnaire related to symptoms and patient satisfaction. The primary analysis will be of time from presentation to diagnosis of women with ovarian cancer in the control group compared to the study group. No data have been published on time to referral in ovarian cancer. There is some limited retrospective data from the USA on the interval from time of presentation to diagnosis.

Primary Outcome(s)

The primary analysis will be of time from presentation to diagnosis of women with ovarian cancer in the control group compared to the study group.

Secondary Outcome(s)

Not provided at time of registration

Secondary ID(s)

N0205116658

Source(s) of Monetary Support

Barts and The London NHS Trust (UK)

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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