Phase 4 of the International Ovarian Tumour Analysis study group: To compare the referral pattern and cost-effectiveness of using Risk of Malignancy Index (RMI) versus Logistic Regression model (LR2) to diagnose adnexal masses prior to surgery
| ISRCTN | ISRCTN20772153 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20772153 |
| Protocol serial number | 10/H0707/28 |
| Sponsor | Imperial College London and Imperial College Healthcare NHS Trust (UK) |
| Funder | Imperial College Healthcare NHS Trust (UK) |
- Submission date
- 16/12/2012
- Registration date
- 04/01/2013
- Last edited
- 30/11/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Contact information
Scientific
Early Pregnancy and Acute Gynaecology Scanning Unit
Queen Charlotte's and Chelsea Hospital
Imperial College London
Hammersmith Campus
Du Cane Road
London
W12 0HS
United Kingdom
 ORCID ID |
0000-0003-1421-6059 |
|---|---|
| Phone | +44 (0)20 8383 5131 |
| t.bourne@imperial.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective multicentre randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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 acronym | IOTA4 |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | Ovarian cancer |
| Intervention | 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 LR2s 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 clinicians final decision regarding treatment) is time zero with follow-up visits 6 weeks, 4 months, and 12 months later. |
| Intervention type | Other |
| Primary outcome measure(s) |
Histological diagnosis (benign or malignant) for patient who undergo surgery. Three follow up findings over one year for conservative management patients. |
| Key secondary outcome measure(s) |
Effectiveness related variables |
| Completion date | 01/07/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 400 |
| Key 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 |
| Key exclusion criteria | 1. Premenopausal women with functional or simple cysts less the 3 cm mean diameter 2. Pregnant women |
| Date of first enrolment | 01/09/2010 |
| Date of final enrolment | 31/05/2012 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Du Cane Rd
London
W12 0HS
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Thesis results | Thesis available at: | 01/07/2015 | No | No |
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
