Targeted screening for ovarian cancer in women over 50 years of age with vague presenting symptoms
| ISRCTN | ISRCTN04011070 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN04011070 |
| Secondary identifying numbers | N0205116658 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 24/05/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Ms Usha Menon
Scientific
Scientific
Gynaecological Research Unit
Charterhouse Square
London
London
EC1M 6GR
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/07/2002 |
| Completion date | 01/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | Not provided at time of registration |
| Key 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. |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/07/2002 |
| Date of final enrolment | 01/12/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Gynaecological Research Unit
London
EC1M 6GR
United Kingdom
EC1M 6GR
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Hospital/treatment centre
Barts and The London NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2007 | Yes | No |
