Condition category
Cancer
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
24/05/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Ms Usha Menon

ORCID ID

Contact details

Gynaecological Research Unit
Charterhouse Square
London
London
EC1M 6GR
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0205116658

Study information

Scientific title

Acronym

Study hypothesis

Ovarian cancer (OC) is the most common gynaecological malignancy in the UK and carries the highest mortality rate. This is believed to be due to the majority of women presenting with late stage disease. The small proportion of women who are diagnosed at an early stage have a significantly improved prognosis, suggesting that diagnosis at an earlier stage may result in a significant improval in survival.

Contrary to widely held views that ovarian cancer is asymptomatic until it reaches a late stage, retrospective studies, based on review of patient notes, suggest that most women diagnosed with OC do report symptoms, although these are usually not gynaecological in nature. These symptoms are mainly vague in nature. The most common symptoms were: increased abdominal size, abdominal bloating, fatigue, abdominal pain, indigestion and urinary frequency. Women also complain of delay in diagnosis due to factors such as incorrect initial diagnosis, initial referral to the wrong specialist, omission of a pelvic examination at the first visit, and not receiving an early ultrasound or CA125 test. The present Cancer Collaborative guidelines for urgent referral do not address the fact that most women present with vague, non gynaecological symptoms.

This study is designed to ascertain whether screening women with vague symptoms, and educating GPs about ovarian cancer symptoms, alters time to diagnosis and stage distribution of OC.

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

GP practices

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Ovarian cancer

Intervention

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.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 measures

Not provided at time of registration

Overall trial start date

01/07/2002

Overall trial end date

01/12/2005

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/07/2002

Recruitment end date

01/12/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Gynaecological Research Unit
London
EC1M 6GR
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

Barts and The London NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17233861

Publication citations

  1. Results

    Rufford BD, Jacobs IJ, Menon U, Feasibility of screening for ovarian cancer using symptoms as selection criteria., BJOG, 2007, 114, 1, 59-64, doi: 10.1111/j.1471-0528.2006.01153.x.

Additional files

Editorial Notes