Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Contact information



Primary contact

Prof Tom Bourne


Contact details

Early Pregnancy and Acute Gynaecology Scanning Unit
Queen Charlotte's and Chelsea Hospital
Imperial College London
Hammersmith Campus
Du Cane Road
W12 0HS
United Kingdom
+44 (0)20 8383 5131

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Randomised controlled trial to compare the referral pattern and cost-effectiveness of using RMI versus LR2 to diagnose adnexal masses prior to surgery



Study hypothesis

This comparison will show that triaging patients using logistic regression model (LR2) is likely to be superior or inferior compared to the currently standard protocol based on the Risk of Malignancy Index (RMI). This may render the preoperative management of adnexal masses.

Ethics approval

1. West London ethics committee, 09/2010, ref: 10/H0707/28
2. Imperial College London and Imperial College Healthcare NHS Trust, 9/12/2010, R&D reference number: BOUT3001

Study design

Prospective multicentre randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please contact to request a patient information sheet


Ovarian cancer


Control arm: diagnosis using the RMI
The RMI is a scoring system based on a logistic regression model to diagnose adnexal masses as benign or malignant (Jacobs et al, 1990). The RMI equals U*M*CA125, where U is the ultrasound score, M the menopausal status score, and CA125 is the level of serum CA125 in u/ml. The ultrasound score is based on five characteristics: multilocular cyst, evidence of solid areas, evidence of metastases, presence of ascites, and bilateral lesions. U equals 0 if none of these characteristics are present, 1 if one characteristic is present, and 3 if two or more characteristics are present. M equals 1 for premenopausal and 3 for postmenopausal women.

Intervention arm: diagnosis using LR2
LR2’s predictors are:
1. Age of the patient (years)
2. The presence of ascites (yes=1, no=0)
3. The presence of blood flow within a papillary projection (yes=1, no=0)
4. Largest diameter of the solid component (expressed in mm but with no increase above 50 mm)
5. Irregular internal cyst walls (yes=1, no=0), and
6. The presence of acoustic shadows (yes=1, no=0). The estimated probability (risk) of malignancy equals 1/(1+e-z), where z = –5.3718 + 0.0354(1) + 1.6159(2) + 1.1768(3) + 0.0697(4) + 0.9586(5) – 2.9486(6). The probability will be multiplied by 100 to yield the percentage risk.

We estimate to enroll the first patient in April 2010, the last patient in July 2012, and the last follow-up visit in July 2013.

Study visits
If surgery is necessary, the day of surgery is time zero with follow-up visits at 2 weeks, 6 weeks, and 12 months from surgery.

If surgery is not necessary, the diagnosis (i.e. the lead clinician’s final decision regarding treatment) is time zero with follow-up visits 6 weeks, 4 months, and 12 months later.

Intervention type



Phase IV

Drug names

Primary outcome measure

Histological diagnosis (benign or malignant) for patient who undergo surgery. Three follow up findings over one year for conservative management patients.

Secondary outcome measures

Effectiveness related variables
1. The percentage of patients with a borderline/invasive mass assigned to the moderate or high risk groups)
2. The actual safety and efficiency based on the real-life referral pattern observed in both study arms (i.e. percentage of patients with a benign mass that are conservatively managed or received local surgery, and the percentage of patients with a borderline or invasive mass that are referred to the cancer unit or cancer centre)
3. The percentage of patients with different types of surgical interventions
4. The median length of hospital stay
5. Health-related quality of life

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Women (non pregnant women above the age of 16) with any abnormal morphology of the ovary evident on an ultrasound scan performed for any clinical symptom
2. Signed and dated informed consent

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Premenopausal women with functional or simple cysts less the 3 cm mean diameter
2. Pregnant women

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Queen Charlotte's and Chelsea Hospital
Early Pregnancy and Acute Gynaecology Scanning Unit Du Cane Rd
W12 0HS
United Kingdom

Sponsor information


Imperial College London and Imperial College Healthcare NHS Trust (UK)

Sponsor details

Becky Ward
Research Governance Manager
Joint Research Compliance Office
Room 5L10A
5th Floor
Lab Block
Charing Cross Hospital
Fulham Palace Road
W6 8RF
United Kingdom
+44 (0)20 3311 0205

Sponsor type

Hospital/treatment centre



Funder type

Hospital/treatment centre

Funder name

Imperial College Healthcare NHS Trust (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

Other non-profit organizations


United Kingdom

Results and Publications

Publication and dissemination plan

The study has been published and disseminated as an open access publication as a PhD thesis with methods/results/discussion and conclusion

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Thesis available at:

Publication citations

Additional files

Editorial Notes

30/11/2017: internal review 07/09/2016: Added thesis publication, changed recruitment end date from 01/07/2013 to 31/05/2012. Added ORCID ID of study contact and ethics approval information 22/06/2016: No publications found, verifying study status with principal investigator