Condition category
Cancer
Date applied
16/12/2012
Date assigned
04/01/2013
Last edited
07/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 multicenter 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
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

Other

Phase

Phase IV

Drug names

Primary outcome measures

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

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

http://www.imperial.ac.uk/clinicalgoveranceoffice

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

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

Results - basic reporting

Publication summary

Thesis available at: https://spiral.imperial.ac.uk:8443/handle/10044/1/34343

Publication citations

Additional files

Editorial Notes

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