Contact information
Type
Scientific
Primary contact
Prof Tom Bourne
ORCID ID
http://orcid.org/0000-0003-1421-6059
Contact details
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
+44 (0)20 8383 5131
t.bourne@imperial.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
10/H0707/28
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
Acronym
IOTA4
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
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please contact a.sayasneh@imperial.ac.uk to request a patient information sheet
Condition
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
Phase
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
01/09/2010
Overall trial end date
01/07/2013
Reason abandoned (if study stopped)
Eligibility
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
Patient
Age group
Adult
Gender
Female
Target number of participants
400
Participant exclusion criteria
1. Premenopausal women with functional or simple cysts less the 3 cm mean diameter
2. Pregnant women
Recruitment start date
01/09/2010
Recruitment end date
31/05/2012
Locations
Countries of recruitment
United Kingdom
Trial 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
Organisation
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
London
W6 8RF
United Kingdom
+44 (0)20 3311 0205
becky.ward@imperial.ac.uk
Sponsor type
Hospital/treatment centre
Website
Funders
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
Location
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: https://spiral.imperial.ac.uk:8443/handle/10044/1/34343