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

Randomised controlled trial to compare the referral pattern and cost-effectiveness of using RMI versus LR2 to diagnose adnexal masses prior to surgery

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN20772153

Enrollment

400

Registered

2013-01-04

Start date

2010-09-01

Completion date

Unknown

Last updated

2017-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian cancer Cancer Malignant neoplasm of ovary

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,

Eligibility

Sex/Gender

Female

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Premenopausal women with functional or simple cysts less the 3 cm mean diameter 2. Pregnant women

Design outcomes

Primary

Measure	Time frame
Histological diagnosis (benign or malignant) for patient who undergo surgery. Three follow up findings over one year for conservative management patients.	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026