Regional study into the performance and cost-effectiveness of simple ultrasound-based rules compared to the currently used Risk of Malignancy Index (RMI) in the diagnosis of ovarian cancer.

Regional study into the performance and cost-effectiveness of simple ultrasound-based rules compared to the currently used Risk of Malignancy Index (RMI) in the diagnosis of ovarian cancer. - Simple Ultrasound Based ruleS to differentiate OvariaN Cysts (SUBSONiC).

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON41648

Enrollment

270

Registered

2014-07-02

Start date

2014-10-24

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

ovarian cancer ovarian carcinoma

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Female patients; Diagnosed in one of the participating centers with at least one pelvic mass that is suspected to be of ovarian origin; Patients who are to undergo surgery in order to obtain a final histological diagnosis; Patients are 18 years of age or older.

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • Pregnant patients; • Patients aged under 18 years; • Patients in whom the surgery does not take place, or takes place more than 120 days after RMI and simple ultrasound-based rules are performed; • Patients with a prior bilateral oophorectomy (removal of both ovaries); • Patients with insufficient or missing data; • Patients who do not give or are incapable of giving an informed consent; • Patients who are not able or willing to travel to the center hospital (MUMC+ at Maastricht) for additional diagnostic procedures.

Design outcomes

Primary

Measure	Time frame
The main study parameters are: 1. Sensitivity; 2. Specificity; 3. Positive and negative predictive values; and 3. Positive and negative likelihood ratios for the correct differentiation between malignant and benign adnexal masses. The diagnosis is based on histology (gold standard) and, in case of a malignancy, the surgical stage. Based on the results of these study parameters a cost-effectiveness and budget impact analysis will be performed.	—

Measure

Time frame

The main study parameters are: 1. Sensitivity; 2. Specificity; 3. Positive and negative predictive values; and 3. Positive and negative likelihood ratios for the correct differentiation between malignant and benign adnexal masses. The diagnosis is based on histology (gold standard) and, in case of a malignancy, the surgical stage. Based on the results of these study parameters a cost-effectiveness and budget impact analysis will be performed.

—

Secondary

Measure	Time frame
Not applicable.	—

Countries

Netherlands

Outcome results