Plain English Summary
Trial website
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
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
-
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.