Comparison of two ultrasound assessment tools for the diagnosis of ovarian tumours in asymptomatic post-menopausal women

ISRCTN	ISRCTN89034131
DOI	https://doi.org/10.1186/ISRCTN89034131
Secondary identifying numbers	10/H0724/48

Submission date: 26/01/2012
Registration date: 30/03/2012
Last edited: 30/09/2020

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

http://www.cancerresearchuk.org/cancer-help/trials/a-trial-comparing-2-ways-examining-managing-ovarian-swellings

Contact information

Miss Natalie Nunes
Scientific

University College London Hospitals
Clinc 3
Elizabeth Garrett Anderson Building
235 Euston Road
London
NW1 2BU
United Kingdom

Study information

Study design	Interventional single centre randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Comparison of intervention rates for the Risk of Malignancy Index (RMI) and the Royal College of Obstetricians and Gynaecologists green top guideline number 34 (October 2003) on postmenopausal cysts with simple ultrasound scan rules by the International Ovarian Tumour Analysis Group (IOTA): a randomised controlled trial
Study objectives	Most asymptomatic ovarian cysts/adnexal masses detected on ultrasound scan are benign. In these women, an operation to remove the cyst is not necessary. By avoiding surgery women are not exposed to surgical and anaesthetic complication and their care is more cost-effective. Postmenopausal women are more likely to suffer from other medical problems such as diabetes and high blood pressure, which increase operative and anaesthetic risks. We do not expect to find a significant difference in the sensitivities for the diagnosis of ovarian cancer between the two protocols. We do expect, however, that the specificity of the new protocol will be better, which should translate into lower intervention rates. This study hopefully will show that use of the Simple Rules and conservative management will reduce intervention rate without significantly increasing risk to the patients. This would increase patient safety and result in significant savings for the NHS.
Ethics approval(s)	North London Research Ethics Committee, 30/09/2010 ref: 10/H0724/48
Health condition(s) or problem(s) studied	Asymptomatic ovarian cysts or adnexal tumours in postmenopausal women
Intervention	Women with presumed benign cysts will be observed over the following year in 3-4 monthly intervals in order to detect any change in appearance or increase in size, which would be suspicious of malignancy. Any suspicion of malignant change, however, would trigger a surgical intervention. Patients will be randomized by pulling sequential sealed envelopes. These envelopes have been prepared from a computer generated randomization list created by the statistician. 1. The Risk of Malignancy Index (RMI) and the Royal College of Obstetricians and Gynaecologists green top guideline number 34 (October 2003) on postmenopausal cysts 2. Simple ultrasound scan rules by the International Ovarian Tumour Analysis Group (IOTA) In both arms of the study women will classified into three groups: 1. Presumed malignant cyst 2. Presumed benign cyst 3. Cysts of indeterminate nature The management strategies will be identical in both arms: 1. Women with presumed malignancies will have surgery or management in a tertiary cancer centre 2. Women with presumed benign cysts will be managed expectantly 3. Women with indeterminate findings will be operated on in local cancer units. Once the scan (+/- blood test) is done all assessments place patient into 1 of 3 categories. The categories are Benign, Indeterminate risk and Malignant. Those with benign tumours are offered 4 monthly scans for 1 year, those with indeterminate tumours are offered surgery in her consultants team and those with malignant tumours are referred to the tertiary oncology team.
Intervention type	Other
Primary outcome measure	The number of surgical interventions in the two study groups
Secondary outcome measures	1. Number of staging laparotomies 2. Diagnostic accuracy of the two protocols 3. Number of blood tests to measure tumour markers 4. Number of surgical complications
Overall study start date	01/04/2011
Completion date	31/03/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	148
Key inclusion criteria	1. Postmenopausal women found to have an ovarian cyst / adnexal mass 2. Postmenopausal women known to have an ovarian cyst / adnexal mass and referred for an opinion 3. Women who do not have any significant pain or bloating not explained but other pathology. Postmenopausal women are defined as those who have had 1 year of spontaneous amenorrhoea above or at the age of 40 where no illness or medication may have caused the amenorrhoea or those above or at the age of 50 who have had a hysterectomy.
Key exclusion criteria	1. Pre-menopausal women 2. Women with pain localised to the area of the cyst or the lower abdomen 3. Women below 40 or above 80 years of age 4. Written informed consent declined or patients unable to give consent 5. Women not medically fit for surgery 6. Women with simple unilateral unilocular cysts of less than 2cm
Date of first enrolment	01/04/2011
Date of final enrolment	31/03/2014

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University College London Hospitals

London
NW1 2BU
United Kingdom

Sponsor information

University College London Hospital NHS Foundation Trust
Hospital/treatment centre

c/o Mr Philip Diamond
235 Euston Road
London
NW1 2BU
England
United Kingdom

Phone	+44 (0)845 155 5000
Email	philip.diamond@uclh.nhs.uk
Website	http://www.uclh.nhs.uk/
"ROR"	https://ror.org/042fqyp44

Funders

Funder type

Hospital/treatment centre

University College London Hospitals NHS Foundation Trust

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	28/02/2017	22/01/2019	Yes	No
Plain English results			30/09/2020	No	Yes

Editorial Notes

30/09/2020: A link to results (plain English) was added.
22/01/2019: Publication reference added
30/09/2016: No publications found, verifying study status with principal investigator