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| [ Print-friendly version ] |
| 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 | 10.1186/ISRCTN20772153 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | 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 |
| 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 |
| Serial number at source | 10/H0707/28 |
| 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. |
| Lay summary | http://www.cancerresearchuk.org/cancer-help/trials/trials-search/a-trial-comparing-different-ways-of-working-out-whether-an-ovarian-cyst-is-cancerous-iota4 |
| Ethics approval |
1. West London REC 1, REC reference number: 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 |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Ovarian cancer |
| Participants - 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 |
| Participants - exclusion criteria |
1. Premenopausal women with functional or simple cysts less the 3 cm mean diameter
2. Pregnant women |
| Anticipated start date | 01/09/2010 |
| Anticipated end date | 01/07/2013 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please contact a.sayasneh@imperial.ac.uk to request a patient information sheet |
| Target number of participants | 400 |
| Interventions |
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. |
| 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. |
| Secondary outcome measure(s) |
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 |
| Sources of funding | Imperial College Healthcare NHS Trust (UK) |
| Trial website | |
| Publications | |
| Contact name | Prof Tom Bourne |
| Address |
Early Pregnancy and Acute Gynaecology Scanning Unit
Queen Charlotte's and Chelsea Hospital Imperial College London Hammersmith Campus Du Cane Road |
| City/town | London |
| Zip/Postcode | W12 0HS |
| Country | United Kingdom |
| Tel | +44 (0)20 8383 5131 |
| t.bourne@imperial.ac.uk | |
| Sponsor | Imperial College London and Imperial College Healthcare NHS Trust (UK) |
| Address |
Becky Ward
Research Governance Manager Joint Research Compliance Office Room 5L10A 5th Floor, Lab Block Charing Cross Hospital Fulham Palace Road |
| City/town | London |
| Zip/Postcode | W6 8RF |
| Country | United Kingdom |
| Tel | +44 (0)20 3311 0205 |
| becky.ward@imperial.ac.uk | |
| Sponsor website: | http://www.imperial.ac.uk/clinicalgoveranceoffice |
| Date applied | 16/12/2012 |
| Last edited | 27/02/2013 |
| Date ISRCTN assigned | 04/01/2013 |
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