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
Secondary identifying numbers	10/H0707/28

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-comparing-different-ways-of-working-out-whether-an-ovarian-cyst-is-cancerous-iota4

Contact information

Prof Tom Bourne
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
Email	t.bourne@imperial.ac.uk

Study information

Study design	Prospective multicentre 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 contact a.sayasneh@imperial.ac.uk to request a patient 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 UMCA125, 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	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 study start date	01/09/2010
Completion date	01/07/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	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

England
United Kingdom

Study participating centre

Queen Charlotte's and Chelsea Hospital

Early Pregnancy and Acute Gynaecology Scanning Unit
Du Cane Rd
London
W12 0HS
United Kingdom

Sponsor information

Imperial College London and Imperial College Healthcare NHS Trust (UK)
Hospital/treatment centre

Becky Ward
Research Governance Manager
Joint Research Compliance Office
Room 5L10A
5th Floor, Lab Block
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
England
United Kingdom

Phone	+44 (0)20 3311 0205
Email	becky.ward@imperial.ac.uk
Website	http://www.imperial.ac.uk/clinicalgoveranceoffice
"ROR"	https://ror.org/041kmwe10

Funders

Funder type

Hospital/treatment centre

Imperial College Healthcare NHS Trust (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): Imperial NHS, imperialnhs, Imperial College Healthcare NHS Trust | London
Location: United Kingdom

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
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