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 logoORCID ID 0000-0003-1421-6059
Phone +44 (0)20 8383 5131
Email t.bourne@imperial.ac.uk

Study information

Study designProspective multicentre randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet Not available in web format, please contact a.sayasneh@imperial.ac.uk to request a patient information sheet
Scientific titleRandomised controlled trial to compare the referral pattern and cost-effectiveness of using RMI versus LR2 to diagnose adnexal masses prior to surgery
Study acronymIOTA4
Study objectivesThis 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) studiedOvarian cancer
InterventionControl 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 typeOther
Primary outcome measureHistological diagnosis (benign or malignant) for patient who undergo surgery. Three follow up findings over one year for conservative management patients.
Secondary outcome measuresEffectiveness 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 date01/09/2010
Completion date01/07/2013

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants400
Key inclusion criteria1. 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 criteria1. Premenopausal women with functional or simple cysts less the 3 cm mean diameter
2. Pregnant women
Date of first enrolment01/09/2010
Date of final enrolment31/05/2012

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 logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planThe 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